NCT02614066 · ADVERSE EVENTS

Adverse events

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) · Source last updated 2024-11-19

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 to 7.1 years
Other-event reporting threshold: 5%

Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.	6 / 6	6 / 6	6 / 6
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.	21 / 23	23 / 23	17 / 28
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.	12 / 16	16 / 16	15 / 20
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.	41 / 55	55 / 55	39 / 71

Group identifiers: EG000: Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg · EG001: Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg · EG002: Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg · EG003: Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg

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 (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Pulseless electrical activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
3
num At Risk
55
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Gastritis

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 (26.1)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
14
num At Risk
23
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
29
num At Risk
55
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Bone marrow reticulin fibrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
23
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
5
num At Risk
55
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
3
num At Risk
55
term
Hypofibrinogenaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
7
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
8
num At Risk
55
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
9
num At Risk
55
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
5
num At Risk
55
term
Bradycardia

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
6
description
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
deaths Num Affected
17
deaths Num At Risk
28
description
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
id
EG001
other Num Affected
23
other Num At Risk
23
serious Num Affected
21
serious Num At Risk
23
title
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
deaths Num Affected
15
deaths Num At Risk
20
description
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
id
EG002
other Num Affected
16
other Num At Risk
16
serious Num Affected
12
serious Num At Risk
16
title
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
deaths Num Affected
39
deaths Num At Risk
71
description
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
id
EG003
other Num Affected
55
other Num At Risk
55
serious Num Affected
41
serious Num At Risk
55
title
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
14
num At Risk
23
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
29
num At Risk
55
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Bone marrow reticulin fibrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
23
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
5
num At Risk
55
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
3
num At Risk
55
term
Hypofibrinogenaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
7
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
8
num At Risk
55
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
9
num At Risk
55
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
5
num At Risk
55
term
Bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
55
term
Pulseless electrical activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
55
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
3
num At Risk
55
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
23
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
55
term
Gastritis

time Frame

Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years

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

Preserved source evidence · Not medical advice