NCT04062448 · ADVERSE EVENTS

Adverse events

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) · Source last updated 2025-05-25

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: All-cause mortality: From Baseline (Day 1) up to 41 months; Serious and other events: From first dose of study drug up to 30 days after last dose of study treatment ((that is, up to 40.6 months)
Other-event reporting threshold: 5%

Safety analysis set included all enrolled participants who received at least 1 dose of ibrutinib. As ibrutinib and rituximab were administered as a combination treatment, adverse events analyses was not performed per the study intervention and thus combined data are presented.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibrutinib + Rituximab Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.	4 / 16	16 / 16	0 / 16

Group identifiers: EG000: Ibrutinib + Rituximab

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
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Heat Illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Arthritis Bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Covid-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Escherichia Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia Bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Heat Illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Dehydration

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 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Iron Deficiency Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Supraventricular Extrasystoles
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Eyelid Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Abdominal Discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
16
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
16
description
Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
id
EG000
other Num Affected
16
other Num At Risk
16
serious Num Affected
4
serious Num At Risk
16
title
Ibrutinib + Rituximab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Iron Deficiency Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Supraventricular Extrasystoles
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Eyelid Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Abdominal Discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
16
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Heat Illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Arthritis Bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Covid-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Escherichia Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Pneumonia Bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
16
term
Heat Illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
16
term
Dehydration

time Frame

All-cause mortality: From Baseline (Day 1) up to 41 months; Serious and other events: From first dose of study drug up to 30 days after last dose of study treatment ((that is, up to 40.6 months)

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Preserved source evidence · Not medical advice