Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma (NCT NCT02348216)
NCT ID: NCT02348216
Last Updated: 2024-06-04
Results Overview
DLT was defined as axicabtagene ciloleucel-related events with onset within first 30 days following infusion: * Grade (GR) 4 neutropenia lasting \> 21 days and GR 4 thrombocytopenia lasting \> 35 days from day of cell transfer; * Any axicabtagene ciloleucel-related AE requiring intubation; * All other GR 3 toxicities lasting \> 3 days and all GR 4 toxicities, with exception of following conditions which were not considered DLTs: aphasia/dysphasia or confusion/cognitive disturbance which resolved to GR ≤ 1 within 2 weeks and to baseline within 4 weeks; fever GR 3; myelosuppression defined as lymphopenia, decreased hemoglobin, neutropenia and thrombocytopenia unless neutropenia and thrombocytopenia met DLT definition described above; immediate hypersensitivity reactions occurring within 2 hours of cell infusion that were reversible to a ≤ GR 2 within 24 hours of cell administration with standard therapy; hypogammaglobulinemia GR 3 or 4.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
307 participants
Primary outcome timeframe
First infusion date of axicabtagene ciloleucel up to 30 days
Results posted on
2024-06-04
Participant Flow
Participants were enrolled at study sites in Canada, France, Germany, Israel, Netherlands, and the United States.
390 participants were screened. Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
Participant milestones
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 1
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 cytokine release syndrome (CRS) for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
81
|
30
|
42
|
46
|
58
|
42
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
81
|
30
|
42
|
46
|
58
|
42
|
Reasons for withdrawal
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 1
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 cytokine release syndrome (CRS) for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
53
|
11
|
20
|
16
|
32
|
17
|
|
Overall Study
Full consent withdrawal
|
0
|
0
|
0
|
1
|
3
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
2
|
0
|
1
|
1
|
1
|
|
Overall Study
Enrolled but did not initiate axicabtagene ciloleucel
|
1
|
4
|
6
|
4
|
5
|
8
|
2
|
|
Overall Study
Reason not specified
|
2
|
19
|
11
|
17
|
21
|
17
|
19
|
Baseline Characteristics
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 1
n=77 Participants
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=38 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
194 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
83 Participants
n=24 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
57 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
53 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
51 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
57 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
58 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
64 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
57 years
STANDARD_DEVIATION 12.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
96 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
181 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
249 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
5 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
223 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
15 participants
n=8 Participants
|
0 participants
n=8 Participants
|
23 participants
n=24 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
9 participants
n=21 Participants
|
13 participants
n=8 Participants
|
8 participants
n=8 Participants
|
30 participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
12 participants
n=21 Participants
|
9 participants
n=8 Participants
|
0 participants
n=8 Participants
|
21 participants
n=24 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
6 participants
n=24 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
11 participants
n=21 Participants
|
13 participants
n=8 Participants
|
6 participants
n=8 Participants
|
35 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
77 participants
n=7 Participants
|
23 participants
n=5 Participants
|
30 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
25 participants
n=8 Participants
|
162 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to 30 daysPopulation: DLT-Evaluable Analysis Set included participants treated in Phase 1 dosing cohort who received the target dose and were followed for at least 30 days after the axicabtagene ciloleucel infusion; or dose of anti-CD19 CAR T cells (axicabtagene ciloleucel) lower than the target for that cohort and experienced a DLT during the 30 day post-infusion period.
DLT was defined as axicabtagene ciloleucel-related events with onset within first 30 days following infusion: * Grade (GR) 4 neutropenia lasting \> 21 days and GR 4 thrombocytopenia lasting \> 35 days from day of cell transfer; * Any axicabtagene ciloleucel-related AE requiring intubation; * All other GR 3 toxicities lasting \> 3 days and all GR 4 toxicities, with exception of following conditions which were not considered DLTs: aphasia/dysphasia or confusion/cognitive disturbance which resolved to GR ≤ 1 within 2 weeks and to baseline within 4 weeks; fever GR 3; myelosuppression defined as lymphopenia, decreased hemoglobin, neutropenia and thrombocytopenia unless neutropenia and thrombocytopenia met DLT definition described above; immediate hypersensitivity reactions occurring within 2 hours of cell infusion that were reversible to a ≤ GR 2 within 24 hours of cell administration with standard therapy; hypogammaglobulinemia GR 3 or 4.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=6 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)Population: The Modified Intent-to-Treat (mITT) analysis set included all participants treated with at least 1.0 x 10\^6 anti-CD19 CAR T cells/kg.
ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; \> 50% decrease in the greatest transverse diameter for single nodules. 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
|
83 percentage of participants
Interval 73.0 to 91.0
|
83 percentage of participants
Interval 63.0 to 95.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)Population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or continuous venovenous hemodialysis (CVVHD), and Grade 5: Death. Neurologic toxicities were graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=38 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 1 CRS
|
34 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 2 CRS
|
55 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 3 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 4 CRS
|
3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 5 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 CRS
|
3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 1 Neurologic Toxicities
|
24 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 2 Neurologic Toxicities
|
21 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 3 Neurologic Toxicities
|
37 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 4 Neurologic Toxicities
|
3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade 5 Neurologic Toxicities
|
3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 Neurologic Toxicities
|
42 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)Population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=41 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 CRS
|
32 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 CRS
|
59 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 CRS
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 CRS
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 Neurologic Toxicities
|
34 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 Neurologic Toxicities
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 Neurologic Toxicities
|
17 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 Neurologic Toxicities
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 Neurologic Toxicities
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 Neurologic Toxicities
|
17 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)Population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=50 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 Neurologic Toxicities
|
12 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 CRS
|
38 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 CRS
|
46 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 CRS
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 CRS
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 Neurologic Toxicities
|
26 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 Neurologic Toxicities
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 Neurologic Toxicities
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 Neurologic Toxicities
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 Neurologic Toxicities
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years)Population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=40 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 CRS
|
35 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 CRS
|
45 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 CRS
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 1 Neurologic Toxicities
|
23 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 2 Neurologic Toxicities
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 3 Neurologic Toxicities
|
8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 4 Neurologic Toxicities
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade 5 Neurologic Toxicities
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Worst Grade ≥ 3 Neurologic Toxicities
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First OR to last follow-up visit (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Cohorts 1, 2, 3, 4, 5, and 6 respectively)Population: Participants in the mITT Analysis Set with objective response were analyzed.
Among participants who experience an objective response (OR), DOR was defined as the date of their first objective response (CR or PR which was subsequently confirmed) to disease progression per the revised IWG Response Criteria for Malignant Lymphoma or death regardless of cause. CR and PR as defined in outcome measure 2. Disease progression (PD) was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. Kaplan-Meier (KM) estimates was used for analyses.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=64 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=20 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=31 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=36 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
|
5.0 months
Interval 2.1 to 34.7
|
75.4 months
Interval 11.1 to
Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Interval 5.0 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Median and upper and lower limit of 95% CI was not estimable because almost 50% of participants were censored.
|
27.5 months
Interval 2.2 to
Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Interval 7.8 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 27 January 2017 (maximum: 20 months)Population: Participants in the Safety Analysis Set were analyzed.
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; \> 50% decrease in the greatest transverse diameter for single nodules.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 1 Study: ORR as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
|
71 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)Population: Participants in the mITT Analysis Set were analyzed.
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; \> 50% decrease in the greatest transverse diameter for single nodules. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): ORR Per Independent Radiological Review Committee (IRRC)
|
70 percentage of participants
Interval 59.0 to 80.0
|
88 percentage of participants
Interval 68.0 to 97.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to last follow-up visit (maximum duration: 6.8, 5.4, 4.4, 4.1 years for Cohorts 3, 4, 5, and 6 respectively)Population: Participants in the mITT Analysis Set were analyzed.
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; \> 50% decrease in the greatest transverse diameter for single nodules. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=38 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=41 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=50 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study (Cohorts 3, 4, 5, and 6): ORR as Assessed by Investigator Per the Revised IWG Response Criteria for Malignant Lymphoma
|
63 percentage of participants
Interval 46.0 to 78.0
|
76 percentage of participants
Interval 60.0 to 88.0
|
72 percentage of participants
Interval 58.0 to 84.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to disease progression or death regardless of cause (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Cohorts 1, 2, 3, 4, 5, and 6 respectively)Population: Participants in the mITT Analysis Set were analyzed.
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Disease progression was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. KM estimates was used for analyses.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=38 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
|
5.1 months
Interval 3.0 to 8.8
|
49.1 months
Interval 3.7 to
Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
6.2 months
Interval 2.4 to
Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Interval 3.0 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
3.1 months
Interval 2.9 to 29.1
|
NA months
Interval 8.7 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to the date of death regardless of cause (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Cohorts 1, 2, 3, 4, 5, and 6 respectively)Population: Participants in the mITT Analysis Set were analyzed.
OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=38 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
15.4 months
Interval 10.4 to 45.7
|
NA months
Interval 15.0 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
34.8 months
Interval 5.4 to
Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Interval 14.6 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
20.6 months
Interval 12.6 to 43.1
|
NA months
Interval 18.9 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
—
|
SECONDARY outcome
Timeframe: First objective response up to the data cutoff date of 11 August 2018 (maximum: 2.7 years)Population: Participants in the mITT Analysis Set with objective response were analyzed.
Among participants who experience an objective response, DOR was defined as the date of their first objective response (CR or PR which was subsequently confirmed) to PD, as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death regardless of cause. CR and PR as defined in outcome measure 2. PD was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. Kaplan-Meier (KM) estimates was used for analyses.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=54 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=21 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Duration of Response (DOR) Using IRRC Per Cheson 2007
|
NA months
Interval 5.4 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
NA months
Interval 11.1 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)Population: Participants in the mITT Analysis Set were analyzed.
The best overall response for each participant was based on the assessments of response (CR, PR, stable disease \[SD\], PD, and not done \[ND\]) made by the the IRRC using IWG 2007 criteria (Cheson et al, 2007). CR and PR as defined in outcome measure 2. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentage of participants with best overall response of CR, PR, SD, PD, and ND was reported.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
CR
|
51 percentage of participants
|
67 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
PR
|
19 percentage of participants
|
21 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
SD
|
21 percentage of participants
|
4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
PD
|
8 percentage of participants
|
4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
ND
|
1 percentage of participants
|
4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)Population: Participants in the mITT Analysis Set were analyzed.
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. KM estimates was used for analyses.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=77 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Pivotal Study (Cohorts 1 and 2): PFS Using IRRC Per Cheson 2007
|
6.9 months
Interval 4.5 to 15.0
|
NA months
Interval 9.0 to
Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow up visit (maximum duration: 7.7 years)Population: Participants in the Safety Analysis Set were analyzed.
An adverse event was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. Adverse events included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an adverse event. TEAE was defined as any AE with onset on or after the start of treatment.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow up visit (maximum duration: 7.7 years)Population: Participants in the Safety Analysis Set were analyzed.
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Laboratory Values Reported as Grade 3 or Higher TEAEs
|
100 percentage of participants
|
96 percentage of participants
|
96 percentage of participants
|
97 percentage of participants
|
98 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Phase 1 and Phase 2 Cohorts 1, 2, 3, 4, 5, and 6 respectively)Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Axicabtagene Ciloleucel Antibodies
|
29 percentage of participants
|
5 percentage of participants
|
8 percentage of participants
|
11 percentage of participants
|
0 percentage of participants
|
8 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 60 (for Phase 1 and Phase 2 Cohorts 1, 2, and 3); Baseline up to Month 24 (for Phase 2 Cohorts 4, 5, and 6)Population: Participants in the Safety Analysis Set with available data were analyzed.
Peak was defined as the maximum number of CAR T cells measured post-infusion.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=6 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=76 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=22 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=36 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=39 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=49 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood
|
58.512 cells/µL
Interval 18.028 to 147.732
|
31.512 cells/µL
Interval 12.445 to 74.746
|
58.633 cells/µL
Interval 27.884 to 103.19
|
53.670 cells/µL
Interval 22.813 to 146.075
|
52.91 cells/µL
Interval 27.25 to 92.78
|
26.63 cells/µL
Interval 12.52 to 117.53
|
64.38 cells/µL
Interval 6.27 to 131.24
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: interferon-gamma induced protein 10 (IP-10), ferritin, granzyme B, intercellular adhesion molecule (ICAM-1), interferon-gamma (IFN-gamma), interleukin-1 receptor antagonist (IL-1RA), IL-2, interleukin-2 receptor alpha (IL-2 R alpha), IL-6, IL-7, IL-8, IL-10, IL-15, perforin, tumor necrosis factor alpha (TNF alpha), and vascular cell adhesion molecule- 1 (VCAM-1).
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IP-10
|
2000.0 pg/mL
Interval 147.0 to 2000.0
|
2000.0 pg/mL
Interval 628.1 to 2000.0
|
2000.0 pg/mL
Interval 434.2 to 2000.0
|
2000.0 pg/mL
Interval 541.0 to 2000.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
Granzyme B
|
33.1 pg/mL
Interval 0.6 to 463.8
|
31.1 pg/mL
Interval 1.0 to 3306.0
|
17.3 pg/mL
Interval 1.0 to 406.8
|
44.1 pg/mL
Interval 1.0 to 534.6
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
ICAM-1
|
792754.3 pg/mL
Interval 537796.8 to 2424877.7
|
1322829.3 pg/mL
Interval 557025.0 to 7495123.2
|
989188.4 pg/mL
Interval 544589.3 to 4588974.8
|
1009966.4 pg/mL
Interval 256768.6 to 4879749.7
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IFN-gamma
|
792.0 pg/mL
Interval 81.1 to 1876.0
|
493.8 pg/mL
Interval 32.4 to 1876.0
|
364.9 pg/mL
Interval 7.5 to 1876.0
|
1857.2 pg/mL
Interval 65.0 to 1876.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-1 RA
|
2173.3 pg/mL
Interval 544.3 to 4000.0
|
2371.2 pg/mL
Interval 510.8 to 4000.0
|
1999.9 pg/mL
Interval 649.9 to 4000.0
|
2160.5 pg/mL
Interval 653.7 to 4000.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-2
|
18.4 pg/mL
Interval 3.1 to 91.0
|
25.0 pg/mL
Interval 0.9 to 123.1
|
13.4 pg/mL
Interval 0.9 to 63.7
|
20.0 pg/mL
Interval 0.9 to 189.4
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-2 R alpha
|
16872.7 pg/mL
Interval 2189.0 to 34044.5
|
14383.7 pg/mL
Interval 78.0 to 100000.0
|
7817.3 pg/mL
Interval 78.0 to 66024.6
|
12386.4 pg/mL
Interval 3002.6 to 100000.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-6
|
305.3 pg/mL
Interval 2.4 to 976.0
|
89.4 pg/mL
Interval 3.5 to 976.0
|
44.6 pg/mL
Interval 3.6 to 976.0
|
921.8 pg/mL
Interval 13.3 to 976.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-7
|
51.5 pg/mL
Interval 31.2 to 71.5
|
38.9 pg/mL
Interval 13.8 to 153.5
|
44.1 pg/mL
Interval 27.9 to 98.8
|
38.8 pg/mL
Interval 19.1 to 83.8
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-8
|
86.4 pg/mL
Interval 17.1 to 750.0
|
118.4 pg/mL
Interval 14.2 to 750.0
|
77.2 pg/mL
Interval 9.8 to 750.0
|
120.9 pg/mL
Interval 10.3 to 750.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-10
|
52.5 pg/mL
Interval 3.8 to 614.0
|
43.9 pg/mL
Interval 0.7 to 466.0
|
18.8 pg/mL
Interval 0.7 to 263.6
|
48.2 pg/mL
Interval 1.8 to 466.0
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
IL-15
|
57.1 pg/mL
Interval 18.7 to 271.3
|
56.5 pg/mL
Interval 13.1 to 226.6
|
47.6 pg/mL
Interval 11.3 to 195.2
|
50.3 pg/mL
Interval 21.9 to 537.3
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
Perforin
|
5389.0 pg/mL
Interval 2582.7 to 20724.3
|
11309.5 pg/mL
Interval 2282.3 to 39818.9
|
8278.7 pg/mL
Interval 2332.6 to 31857.7
|
15411.9 pg/mL
Interval 4327.4 to 30575.9
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
TNF alpha
|
10.5 pg/mL
Interval 1.8 to 443.1
|
8.6 pg/mL
Interval 2.6 to 166.9
|
6.8 pg/mL
Interval 2.2 to 44.9
|
10.9 pg/mL
Interval 3.3 to 52.1
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
VCAM-1
|
1387033.6 pg/mL
Interval 609223.2 to 8424222.9
|
1478356.8 pg/mL
Interval 642372.6 to 3859375.8
|
1058453.9 pg/mL
Interval 634769.7 to 2864040.2
|
1367940.7 pg/mL
Interval 721050.0 to 5184238.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set with available data were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: IP-10, granzyme B, IFN-gamma, IL-1 RA, IL-2, IL-6, IL-7, IL-8, IL-10, IL-15, TNF alpha, and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=41 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=50 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=40 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IP-10
|
1549.70 pg/mL
Interval 469.2 to 2000.0
|
1746.15 pg/mL
Interval 349.8 to 2000.0
|
1560.03 pg/mL
Interval 347.0 to 2000.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
Granzyme B
|
23.10 pg/mL
Interval 1.0 to 322.6
|
27.90 pg/mL
Interval 1.0 to 375.76
|
18.40 pg/mL
Interval 1.0 to 162.3
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IFN-gamma
|
334.50 pg/mL
Interval 24.9 to 1876.0
|
314.90 pg/mL
Interval 7.5 to 1876.0
|
207.95 pg/mL
Interval 18.8 to 1876.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-1 RA
|
1093.70 pg/mL
Interval 193.3 to 4493.1
|
908.00 pg/mL
Interval 229.0 to 9000.0
|
1279.50 pg/mL
Interval 227.0 to 9000.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-2
|
11.20 pg/mL
Interval 0.9 to 79.4
|
11.85 pg/mL
Interval 0.9 to 142.7
|
8.40 pg/mL
Interval 0.9 to 277.6
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-6
|
136.70 pg/mL
Interval 1.6 to 976.0
|
97.95 pg/mL
Interval 1.6 to 976.0
|
47.25 pg/mL
Interval 1.6 to 976.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-7
|
33.10 pg/mL
Interval 18.0 to 67.5
|
29.80 pg/mL
Interval 1.4 to 65.2
|
28.25 pg/mL
Interval 13.2 to 74.3
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-8
|
67.40 pg/mL
Interval 8.5 to 750.0
|
75.10 pg/mL
Interval 5.8 to 750.0
|
52.55 pg/mL
Interval 10.0 to 750.0
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-10
|
19.60 pg/mL
Interval 1.4 to 466.0
|
14.45 pg/mL
Interval 0.7 to 300.9
|
13.30 pg/mL
Interval 0.7 to 171.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-15
|
45.80 pg/mL
Interval 22.3 to 272.7
|
34.15 pg/mL
Interval 1.4 to 140.0
|
37.20 pg/mL
Interval 9.5 to 86.3
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
TNF alpha
|
5.70 pg/mL
Interval 2.0 to 54.6
|
5.25 pg/mL
Interval 1.4 to 33.3
|
4.80 pg/mL
Interval 2.1 to 20.2
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
GM-CSF
|
4.40 pg/mL
Interval 1.9 to 47.0
|
2.90 pg/mL
Interval 1.9 to 35.6
|
1.90 pg/mL
Interval 1.9 to 47.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=41 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=50 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=40 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
Ferritin
|
1086.36 ng/mL
Interval 95.55 to 23900.0
|
1516.11 ng/mL
Interval 89.29 to 31600.0
|
903.50 ng/mL
Interval 171.61 to 6555.1
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
ICAM-1
|
907.97 ng/mL
Interval 359.51 to 5141.64
|
636.74 ng/mL
Interval 361.38 to 4835.93
|
654.81 ng/mL
Interval 355.15 to 4419.09
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
IL-2 R
|
10.78 ng/mL
Interval 2.81 to 94.59
|
7.82 ng/mL
Interval 1.36 to 83.6
|
6.43 ng/mL
Interval 1.7 to 33.31
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
Perforin
|
17.22 ng/mL
Interval 3.88 to 44.42
|
10.85 ng/mL
Interval 2.53 to 100.0
|
10.12 ng/mL
Interval 1.97 to 39.62
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
VCAM-1
|
1255.32 ng/mL
Interval 594.51 to 3932.61
|
854.63 ng/mL
Interval 476.6 to 6501.14
|
836.04 ng/mL
Interval 411.93 to 5079.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokine (CRP) in Serum
|
112.6 mg/mL
Interval 14.6 to 655.0
|
215.7 mg/mL
Interval 31.0 to 496.0
|
186.6 mg/mL
Interval 18.5 to 496.0
|
137.8 mg/mL
Interval 2.1 to 496.0
|
126.53 mg/mL
Interval 18.19 to 496.0
|
74.84 mg/mL
Interval 1.81 to 496.0
|
76.11 mg/mL
Interval 7.31 to 496.0
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2)
|
1973400.0 pg/mL
Interval 1201900.0 to 32984400.0
|
3681400.0 pg/mL
Interval 780.0 to 25000000.0
|
1979360.0 pg/mL
Interval 780.0 to 25000000.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Participants in the Safety Analysis Set were analyzed.
Peak was defined as the maximum post-baseline level of the cytokine.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=38 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 2 Cohort 3)
|
2440.2 ng/mL
Interval 0.8 to 25000.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-infusion) up to last follow-up visit (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Phase 1 and Phase 2 Cohorts 1, 2, 3, 4, 5, and 6 respectively)Population: Participants in the Safety Analysis Set were analyzed.
RCR was analyzed in blood samples by central laboratory. Because axicabtagene ciloleucel comprised retroviral vector transduced T cells, the presence of RCR in the blood of treated participants was reported.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=77 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=24 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=38 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=41 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=50 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
n=40 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Replication Competent Retrovirus (RCR)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Month 3, and Month 6Population: 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 scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was divided into 5 levels of severity: "No problem", "Slight problems", "Moderate problems", "Severe problems", and "Extreme problems (unable to perform)". EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=38 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=39 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=47 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=34 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Self-care · Severe problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Mobility · No problem
|
30 Participants
|
25 Participants
|
33 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Mobility · Slight problem
|
7 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Mobility · Moderate problem
|
1 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Mobility · Severe problem
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Mobility · Unable to perform
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Mobility · Slight problem
|
11 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Mobility · Moderate problem
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Mobility · Severe problem
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Mobility · Unable to perform
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Mobility · No problem
|
14 Participants
|
20 Participants
|
21 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Mobility · Slight problem
|
6 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Mobility · Moderate problem
|
2 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Mobility · Severe problem
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Mobility · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Mobility · No problem
|
10 Participants
|
19 Participants
|
11 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Mobility · Slight problem
|
6 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Mobility · Moderate problem
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Mobility · Severe problem
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Mobility · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Self-care · No problem
|
37 Participants
|
38 Participants
|
44 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Self-care · Slight problem
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Self-care · Moderate problem
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Self-care · Severe problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Self-care · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Self-care · No problem
|
25 Participants
|
33 Participants
|
31 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Self-care · Slight problem
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Self-care · Moderate problem
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Self-care · Severe problem
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Self-care · Unable to perform
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Self-care · No problem
|
19 Participants
|
29 Participants
|
32 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Self-care · Slight problem
|
4 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Self-care · Moderate problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Self-care · Severe problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Self-care · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Self-care · No problem
|
17 Participants
|
25 Participants
|
16 Participants
|
20 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Self-care · Slight problem
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Self-care · Moderate problem
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Self-care · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Usual activities · No problem
|
22 Participants
|
22 Participants
|
24 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Usual activities · Slight problem
|
10 Participants
|
6 Participants
|
13 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Usual activities · Moderate problem
|
4 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Usual activities · Severe problem
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Usual activities · Unable to perform
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Usual activities · No problem
|
6 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Usual activities · Slight problem
|
13 Participants
|
11 Participants
|
13 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Usual activities · Moderate problem
|
11 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Usual activities · Severe problem
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Usual activities · Unable to perform
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Usual activities · No problem
|
8 Participants
|
16 Participants
|
19 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Usual activities · Slight problem
|
9 Participants
|
9 Participants
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Usual activities · Moderate problem
|
5 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Usual activities · Severe problem
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Usual activities · Unable to perform
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Usual activities · No problem
|
9 Participants
|
15 Participants
|
10 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Usual activities · Slight problem
|
5 Participants
|
7 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Usual activities · Moderate problem
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Usual activities · Severe problem
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Mobility · No problem
|
16 Participants
|
21 Participants
|
23 Participants
|
20 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Usual activities · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Pain/Discomfort · Moderate problem
|
8 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Pain/Discomfort · Severe problem
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Pain/Discomfort · Unable to perform
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Pain/Discomfort · No problem
|
12 Participants
|
19 Participants
|
20 Participants
|
17 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Pain/Discomfort · Slight problem
|
12 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Pain/Discomfort · Moderate problem
|
7 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Pain/Discomfort · Severe problem
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Pain/Discomfort · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Pain/Discomfort · No problem
|
9 Participants
|
10 Participants
|
18 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Pain/Discomfort · Slight problem
|
5 Participants
|
14 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Pain/Discomfort · Moderate problem
|
9 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Pain/Discomfort · Severe problem
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Pain/Discomfort · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Pain/Discomfort · No problem
|
8 Participants
|
9 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Pain/Discomfort · Slight problem
|
4 Participants
|
14 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Pain/Discomfort · Moderate problem
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Pain/Discomfort · Severe problem
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Pain/Discomfort · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Anxiety/Depression · No problem
|
16 Participants
|
23 Participants
|
18 Participants
|
21 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Anxiety/Depression · Slight problem
|
16 Participants
|
13 Participants
|
17 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Anxiety/Depression · Moderate problem
|
3 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Anxiety/Depression · Severe problem
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Anxiety/Depression · Unable to perform
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Anxiety/Depression · No problem
|
9 Participants
|
25 Participants
|
21 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Anxiety/Depression · Slight problem
|
15 Participants
|
8 Participants
|
12 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Anxiety/Depression · Moderate problem
|
7 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Anxiety/Depression · Severe problem
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Week 4: Anxiety/Depression · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Anxiety/Depression · No problem
|
11 Participants
|
19 Participants
|
16 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Anxiety/Depression · Slight problem
|
5 Participants
|
8 Participants
|
12 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Anxiety/Depression · Moderate problem
|
6 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Anxiety/Depression · Severe problem
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 3: Anxiety/Depression · Unable to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Anxiety/Depression · No problem
|
9 Participants
|
14 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Anxiety/Depression · Slight problem
|
5 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Anxiety/Depression · Moderate problem
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Pain/Discomfort · No problem
|
18 Participants
|
17 Participants
|
16 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Baseline: Pain/Discomfort · Slight problem
|
9 Participants
|
17 Participants
|
18 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Anxiety/Depression · Severe problem
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Month 6: Anxiety/Depression · Unable to perform
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Month 3, and Month 6Population: 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-VAS records the participant's self-rated health on a 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.
Outcome measures
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=38 Participants
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=38 Participants
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=47 Participants
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=34 Participants
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
|---|---|---|---|---|---|---|---|
|
Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score
Baseline
|
71.2 units on a scale
Standard Deviation 21.3
|
69.5 units on a scale
Standard Deviation 18.8
|
66.7 units on a scale
Standard Deviation 20.7
|
70.9 units on a scale
Standard Deviation 17.0
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score
Week 4
|
67.8 units on a scale
Standard Deviation 15.6
|
67.2 units on a scale
Standard Deviation 20.9
|
70.8 units on a scale
Standard Deviation 14.8
|
76.1 units on a scale
Standard Deviation 13.2
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score
Month 3
|
74.9 units on a scale
Standard Deviation 16.6
|
78.8 units on a scale
Standard Deviation 14.7
|
73.3 units on a scale
Standard Deviation 19.9
|
76.5 units on a scale
Standard Deviation 15.0
|
—
|
—
|
—
|
|
Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score
Month 6
|
77.1 units on a scale
Standard Deviation 21.4
|
85.1 units on a scale
Standard Deviation 12.1
|
77.1 units on a scale
Standard Deviation 14.7
|
79.8 units on a scale
Standard Deviation 14.0
|
—
|
—
|
—
|
Adverse Events
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 2 (Pivotal Study): Cohort 1
Serious events: 40 serious events
Other events: 77 other events
Deaths: 49 deaths
Phase 2 (Pivotal Study): Cohort 2
Serious events: 14 serious events
Other events: 23 other events
Deaths: 13 deaths
Phase 2 (Safety Management Study): Cohort 3
Serious events: 26 serious events
Other events: 38 other events
Deaths: 23 deaths
Phase 2 (Safety Management Study): Cohort 4
Serious events: 24 serious events
Other events: 41 other events
Deaths: 20 deaths
Phase 2 (Safety Management Study): Cohort 5
Serious events: 27 serious events
Other events: 50 other events
Deaths: 37 deaths
Phase 2 (Safety Management Study): Cohort 6
Serious events: 25 serious events
Other events: 40 other events
Deaths: 20 deaths
Retreatment Axicabtagene Ciloleucel: Phase 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1
Serious events: 5 serious events
Other events: 9 other events
Deaths: 8 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 participants at risk
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 1
n=77 participants at risk
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 participants at risk
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=38 participants at risk
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=41 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=50 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=40 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Retreatment Axicabtagene Ciloleucel: Phase 1
n=1 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1
n=9 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Eye disorders
Visual impairment
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
General physical health deterioration
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Covid-19
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Human herpesvirus 6 encephalitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Meningitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Myelitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.1%
7/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pseudomonal sepsis
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Rotavirus infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Septic shock
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Troponin T increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dyspraxia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Encephalopathy
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
16/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Haemorrhage intracranial
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Presyncope
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
5/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Reexpansion pulmonary oedema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Embolism
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Shock
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
Other adverse events
| Measure |
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
n=7 participants at risk
Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel 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 (BW) on Day 0.
|
Phase 2 (Pivotal Study): Cohort 1
n=77 participants at risk
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Pivotal Study): Cohort 2
n=24 participants at risk
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
|
Phase 2 (Safety Management Study): Cohort 3
n=38 participants at risk
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
|
Phase 2 (Safety Management Study): Cohort 4
n=41 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Phase 2 (Safety Management Study): Cohort 5
n=50 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
|
Phase 2 (Safety Management Study): Cohort 6
n=40 participants at risk
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
|
Retreatment Axicabtagene Ciloleucel: Phase 1
n=1 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1
n=9 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5
n=2 participants at risk
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6
Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
61.0%
47/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
54.2%
13/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
57.9%
22/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
46.3%
19/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
38.0%
19/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
32.5%
13/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
27.3%
21/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.3%
10/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.9%
13/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.1%
7/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.0%
8/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.5%
7/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.8%
26/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
12/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
47.4%
18/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
39.0%
16/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
32.0%
16/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
20/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
31.2%
24/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
31.6%
12/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.1%
7/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
18.0%
9/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
10/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Acute left ventricular failure
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.7%
19/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
5/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.4%
4/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Tachycardia
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
37.7%
29/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.8%
6/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.1%
7/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.0%
7/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Ventricular arrhythmia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.4%
8/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
5/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
19.5%
15/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
5/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
18.4%
7/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.0%
8/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
37.5%
15/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
71.4%
5/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
37.7%
29/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
42.1%
16/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
61.0%
25/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.0%
11/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
27.5%
11/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.1%
7/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.6%
22/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
12/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
39.5%
15/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.3%
12/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.0%
12/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
35.0%
14/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.4%
4/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.1%
17/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
45.8%
11/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.0%
7/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
8/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
5/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Catheter site pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Chills
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
41.6%
32/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.2%
7/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.9%
11/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.8%
11/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.0%
14/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
8/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.2%
34/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
12/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
47.4%
18/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
46.3%
19/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.0%
12/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
45.0%
18/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Hernia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Malaise
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Oedema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.6%
12/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.8%
6/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Puncture site pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Pyrexia
|
100.0%
7/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
85.7%
66/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
87.5%
21/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
92.1%
35/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
95.1%
39/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
80.0%
40/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
82.5%
33/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
9/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
General disorders
Swelling
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.0%
10/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
8/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Covid-19
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Ear infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Herpes zoster
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Sinusitis
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Tinea versicolour
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
18.4%
7/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.9%
13/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
5/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
21.1%
8/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.0%
7/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.3%
11/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
5/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
18.4%
7/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.0%
7/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood albumin decreased
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood magnesium decreased
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.0%
7/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Lymphocyte count decreased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.6%
12/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.0%
8/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.5%
7/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
35.1%
27/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.2%
7/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.9%
11/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
31.7%
13/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
25/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
35.0%
14/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.4%
4/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
32.5%
25/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
5/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.4%
10/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
34.0%
17/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Urine output decreased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Weight decreased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.3%
11/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
Weight increased
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Investigations
White blood cell count decreased
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.9%
23/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.3%
10/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.0%
14/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
10/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
40.3%
31/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
12/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.3%
10/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.0%
6/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
8/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.4%
4/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.6%
12/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.8%
6/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
28.6%
22/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
37.5%
9/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.9%
23/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
45.8%
11/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.9%
23/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.8%
6/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
10/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
27.5%
11/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.8%
6/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.0%
20/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
41.7%
10/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.7%
19/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
27.5%
11/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.6%
12/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.5%
9/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.9%
13/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.3%
11/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.0%
10/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.1%
7/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Aphasia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.9%
13/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
21.1%
8/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
18.0%
9/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dementia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.6%
12/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
37.5%
9/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.1%
7/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.0%
8/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Dyskinesia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Encephalopathy
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.0%
20/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.2%
34/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
12/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
19/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
39.0%
16/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
34.0%
17/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
32.5%
13/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
2/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.8%
6/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Poor sucking reflex
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Post herpetic neuralgia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Somnolence
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.0%
10/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
5/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Nervous system disorders
Tremor
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
29.9%
23/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
42.1%
16/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.2%
5/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.0%
11/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.5%
9/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
44.4%
4/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.7%
9/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.5%
3/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
24.7%
19/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
8/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
42.1%
16/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.8%
4/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.0%
6/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
30.0%
12/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Delirium
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Hallucination
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.1%
7/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
33.3%
3/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Psychiatric disorders
Restlessness
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.8%
6/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
9.1%
7/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.5%
4/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.4%
18/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
25.0%
6/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
26.8%
11/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
12.0%
6/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
15.0%
6/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
55.6%
5/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.3%
11/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.3%
3/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.0%
4/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.0%
8/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
3.9%
3/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
57.1%
4/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
31.2%
24/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
20.8%
5/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
23.7%
9/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
14.6%
6/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
5/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
17.5%
7/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
22.2%
2/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.7%
9/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
13.2%
5/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
28.6%
2/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.5%
5/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.9%
3/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.2%
4/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.0%
1/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
1.3%
1/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.8%
6/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
8.3%
2/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
1/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.2%
1/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.0%
2/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.5%
1/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Capillary leak syndrome
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.4%
1/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
2.6%
2/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
7.5%
3/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Embolism
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.0%
2/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.7%
9/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
16.7%
4/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
5.3%
2/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
4.9%
2/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
6.0%
3/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
10.0%
4/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Hypotension
|
42.9%
3/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
57.1%
44/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
58.3%
14/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
57.9%
22/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
58.5%
24/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
25/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
52.5%
21/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
100.0%
1/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
11.1%
1/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/7 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/77 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/24 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/38 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/41 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/50 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/40 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/1 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/9 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
50.0%
1/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
0.00%
0/2 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
—
0/0 • Adverse event: Up to 7.7 years; All-cause mortality: Enrollment up to last follow up visit (maximum duration: 7.7 years; The number of deaths reported in the Participant Flow for Phase 2 Cohort 1 (53) is more than the number of deaths reported in the All-Cause Mortality for Phase 2 Cohort 1 (49) within the table below because the deaths that occurred in the main phase and retreatment phase arms are being reported separately.
Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.
|
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