NCT03357952 · ADVERSE EVENTS

Adverse events

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-02-04

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: Up to 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Daratumumab + JNJ-63723283 Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	3 / 9	9 / 9	0 / 9
Part 2: Daratumumab (Arm A) Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: Part 1: Daratumumab + JNJ-63723283 · EG001: Part 2: Daratumumab (Arm A)

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 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Septic Shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Encephalitis Autoimmune
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Acute Kidney Injury

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 21.0
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
4
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Corneal Degeneration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Dyspepsia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
9
description
Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
id
EG000
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Part 1: Daratumumab + JNJ-63723283
deaths Num Affected
0
deaths Num At Risk
1
description
Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 2: Daratumumab (Arm A)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
4
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Corneal Degeneration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Dyspepsia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Septic Shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Encephalitis Autoimmune
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 21.0
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
1
term
Acute Kidney Injury

time Frame

Up to 2 years

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Preserved source evidence · Not medical advice