NCT03277729 · ADVERSE EVENTS

Adverse events

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas · Source last updated 2026-06-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 0 of CD20 CAR T Cells Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV	1 / 1	1 / 1	0 / 1
Dose Level 1 of CD20 CAR T Cells Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV	2 / 8	8 / 8	2 / 8
Dose Level 2 of CD20 CAR T Cells Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV	1 / 4	4 / 4	3 / 4
Dose Level 3 of CD20 CAR-T Cells Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV	2 / 6	6 / 6	3 / 6
Dose Level 4 of CD20 CAR-T Cells Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV	18 / 31	31 / 31	7 / 31

Group identifiers: EG000: Dose Level 0 of CD20 CAR T Cells · EG001: Dose Level 1 of CD20 CAR T Cells · EG002: Dose Level 2 of CD20 CAR T Cells · EG003: Dose Level 3 of CD20 CAR-T Cells · EG004: Dose Level 4 of CD20 CAR-T Cells

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
12
num At Risk
31
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
31
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
31
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
31
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
31
term
Immune system disorders
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID19
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
General disorders and administration site conditions - Other, COVID
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
31
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Dysarthria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Leukemia secondary to oncology chemotherapy

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
8
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
6
num At Risk
6
group Id
EG004
num Affected
28
num At Risk
31
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
7
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
5
num At Risk
6
group Id
EG004
num Affected
29
num At Risk
31
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
8
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
5
num At Risk
6
group Id
EG004
num Affected
28
num At Risk
31
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
6
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
25
num At Risk
31
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
7
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Hypocalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
4
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
10
num At Risk
31
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
8
num At Risk
31
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Headache

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Dose Level 0 of CD20 CAR T Cells
deaths Num Affected
2
deaths Num At Risk
8
description
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Dose Level 1 of CD20 CAR T Cells
deaths Num Affected
3
deaths Num At Risk
4
description
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Dose Level 2 of CD20 CAR T Cells
deaths Num Affected
3
deaths Num At Risk
6
description
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Dose Level 3 of CD20 CAR-T Cells
deaths Num Affected
7
deaths Num At Risk
31
description
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
id
EG004
other Num Affected
31
other Num At Risk
31
serious Num Affected
18
serious Num At Risk
31
title
Dose Level 4 of CD20 CAR-T Cells

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
8
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
6
num At Risk
6
group Id
EG004
num Affected
28
num At Risk
31
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
7
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
5
num At Risk
6
group Id
EG004
num Affected
29
num At Risk
31
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
8
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
4
group Id
EG003
num Affected
5
num At Risk
6
group Id
EG004
num Affected
28
num At Risk
31
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
6
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
25
num At Risk
31
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
7
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
13
num At Risk
31
term
Hypocalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
4
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
10
num At Risk
31
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
8
num At Risk
31
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
7
num At Risk
31
term
Headache

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
12
num At Risk
31
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
3
num At Risk
31
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
5
num At Risk
31
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
31
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
31
term
Immune system disorders
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID19
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
General disorders and administration site conditions - Other, COVID
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
31
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Dysarthria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
31
term
Leukemia secondary to oncology chemotherapy

time Frame

Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice