NCT03548207 · ADVERSE EVENTS

Adverse events

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-07-30

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: Day 1 up to 45.2 months
Other-event reporting threshold: 5%

All treated analysis set included all participants who received JNJ-68284528 infusion.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1b (US Population) Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	11 / 29	29 / 29	10 / 29
Phase 2 (US Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	42 / 68	68 / 68	25 / 68
Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	1 / 9	9 / 9	3 / 9

Group identifiers: EG000: Phase 1b (US Population) · EG001: Phase 2 (US Population) · EG002: Phase 2 (Japan Population)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
3
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
2
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Diplopia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Haematochezia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Gait Disturbance

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
22
num At Risk
29
group Id
EG001
num Affected
57
num At Risk
68
group Id
EG002
num Affected
6
num At Risk
9
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
3
num At Risk
9
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
11
num At Risk
68
group Id
EG002
num Affected
2
num At Risk
9
term
Hypofibrinogenaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
20
num At Risk
29
group Id
EG001
num Affected
40
num At Risk
68
group Id
EG002
num Affected
4
num At Risk
9
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
2
num At Risk
9
term
Lymphocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
16
num At Risk
29
group Id
EG001
num Affected
35
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
29
num At Risk
29
group Id
EG001
num Affected
64
num At Risk
68
group Id
EG002
num Affected
8
num At Risk
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
25
num At Risk
29
group Id
EG001
num Affected
51
num At Risk
68
group Id
EG002
num Affected
7
num At Risk
9
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
12
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Sinus Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
7
num At Risk
29
group Id
EG001
num Affected
14
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Constipation

Complete source fields

description

All treated analysis set included all participants who received JNJ-68284528 infusion.

event Groups

deaths Num Affected
10
deaths Num At Risk
29
description
Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
id
EG000
other Num Affected
29
other Num At Risk
29
serious Num Affected
11
serious Num At Risk
29
title
Phase 1b (US Population)
deaths Num Affected
25
deaths Num At Risk
68
description
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
id
EG001
other Num Affected
68
other Num At Risk
68
serious Num Affected
42
serious Num At Risk
68
title
Phase 2 (US Population)
deaths Num Affected
3
deaths Num At Risk
9
description
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
id
EG002
other Num Affected
9
other Num At Risk
9
serious Num Affected
1
serious Num At Risk
9
title
Phase 2 (Japan Population)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
22
num At Risk
29
group Id
EG001
num Affected
57
num At Risk
68
group Id
EG002
num Affected
6
num At Risk
9
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
3
num At Risk
9
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
11
num At Risk
68
group Id
EG002
num Affected
2
num At Risk
9
term
Hypofibrinogenaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
20
num At Risk
29
group Id
EG001
num Affected
40
num At Risk
68
group Id
EG002
num Affected
4
num At Risk
9
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
2
num At Risk
9
term
Lymphocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
16
num At Risk
29
group Id
EG001
num Affected
35
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
29
num At Risk
29
group Id
EG001
num Affected
64
num At Risk
68
group Id
EG002
num Affected
8
num At Risk
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
25
num At Risk
29
group Id
EG001
num Affected
51
num At Risk
68
group Id
EG002
num Affected
7
num At Risk
9
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
4
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
12
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Sinus Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
6
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
7
num At Risk
29
group Id
EG001
num Affected
14
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
3
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
2
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Diplopia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Haematochezia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
1
num At Risk
9
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
68
group Id
EG002
num Affected
0
num At Risk
9
term
Gait Disturbance

time Frame

Day 1 up to 45.2 months

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

Preserved source evidence · Not medical advice