NCT02601313 · ADVERSE EVENTS

Adverse events

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18

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 Event: Up to 5 years; All cause mortality: Up to 7.8 years
Other-event reporting threshold: 5%

Full Analysis Set included all enrolled participants. Safety Analysis Set included all participants treated with any dose of study drug. The Safety-Retreatment Analysis Set included all participants with re-treatment of KTE-X19 from Safety Analysis Set. All cause mortality was based on Full Analysis Set. SAE and other AE were based on the Safety Analysis Set.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
2 x 10^6 Axicabtagene Ciloleucel Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg on Day 0.	8 / 10	10 / 10	9 / 14
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.	49 / 68	68 / 68	42 / 74
Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.	9 / 14	14 / 14	9 / 17
Retreatment Cohort 1 Participants with relapsed/refractory MCL received a retreatment with conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg at Month 3.	3 / 5	5 / 5	5 / 5
Retreatment Cohort 2 Participants with relapsed/refractory MCL received a retreatment with conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg at Month 3	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: 2 x 10^6 Axicabtagene Ciloleucel · EG001: Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel · EG002: Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel · EG003: Retreatment Cohort 1 · EG004: Retreatment Cohort 2

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
2
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Autoimmune colitis

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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
10
group Id
EG001
num Affected
46
num At Risk
68
group Id
EG002
num Affected
7
num At Risk
14
group Id
EG003
num Affected
4
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
5
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
11
num At Risk
68
group Id
EG002
num Affected
4
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
5
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
25
num At Risk
68
group Id
EG002
num Affected
5
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
15
num At Risk
68
group Id
EG002
num Affected
3
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiac flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiomyopathy acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Palpitations

Complete source fields

description

event Groups

deaths Num Affected
9
deaths Num At Risk
14
description
Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg on Day 0.
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
2 x 10^6 Axicabtagene Ciloleucel
deaths Num Affected
42
deaths Num At Risk
74
description
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
id
EG001
other Num Affected
68
other Num At Risk
68
serious Num Affected
49
serious Num At Risk
68
title
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
deaths Num Affected
9
deaths Num At Risk
17
description
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
id
EG002
other Num Affected
14
other Num At Risk
14
serious Num Affected
9
serious Num At Risk
14
title
Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
deaths Num Affected
5
deaths Num At Risk
5
description
Participants with relapsed/refractory MCL received a retreatment with conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg at Month 3.
id
EG003
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Retreatment Cohort 1
deaths Num Affected
0
deaths Num At Risk
1
description
Participants with relapsed/refractory MCL received a retreatment with conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg at Month 3
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Retreatment Cohort 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
10
group Id
EG001
num Affected
46
num At Risk
68
group Id
EG002
num Affected
7
num At Risk
14
group Id
EG003
num Affected
4
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
5
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
11
num At Risk
68
group Id
EG002
num Affected
4
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
5
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
25
num At Risk
68
group Id
EG002
num Affected
5
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
15
num At Risk
68
group Id
EG002
num Affected
3
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiac flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiomyopathy acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
2
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
14
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
1
term
Autoimmune colitis

time Frame

Adverse Event: Up to 5 years; All cause mortality: Up to 7.8 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice