NCT04042376 · ADVERSE EVENTS

Adverse events

A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory 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 Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
Other-event reporting threshold: 5%

All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibrutinib 420 mg Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.	9 / 17	17 / 17	3 / 17

Group identifiers: EG000: Ibrutinib 420 mg

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 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Anal Abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Bacterial Prostatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Orchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lumbar Vertebral Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lung Squamous Cell Carcinoma Stage 0
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Haemorrhage Intracranial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Peripheral Sensory Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Ureterolithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pleural Effusion

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 26.1
stats
group Id
EG000
num Affected
6
num At Risk
17
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Ventricular Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Retinal Haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
3
deaths Num At Risk
17
description
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
9
serious Num At Risk
17
title
Ibrutinib 420 mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
6
num At Risk
17
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Ventricular Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Retinal Haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Diarrhoea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Anal Abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Bacterial Prostatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Orchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lumbar Vertebral Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Lung Squamous Cell Carcinoma Stage 0
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Haemorrhage Intracranial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Peripheral Sensory Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Ureterolithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pleural Effusion

time Frame

All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)

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Preserved source evidence · Not medical advice