NCT04548648 · ADVERSE EVENTS

Adverse events

A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas · Source last updated 2026-06-10

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 3 years.
Other-event reporting threshold: 0%

All hospital admissions were considered as serious adverse event per protocol.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Open-label, Single-arm Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.	5 / 10	10 / 10	5 / 10

Group identifiers: EG000: Open-label, Single-arm

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
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gait Disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Creatinine Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypophosphatemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Generalized Muscle Weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Encephalopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Spinal Cord Compression

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
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
10
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
10
term
Blood And Lymphatic System Disorders - Other, Specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Blurred Vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
10
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gastroesophageal Reflux Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Nausea

Complete source fields

description

All hospital admissions were considered as serious adverse event per protocol.

event Groups

deaths Num Affected
5
deaths Num At Risk
10
description
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Open-label, Single-arm

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
10
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
10
term
Blood And Lymphatic System Disorders - Other, Specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Blurred Vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
10
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gastroesophageal Reflux Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Nausea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gait Disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Creatinine Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypophosphatemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Generalized Muscle Weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Encephalopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Spinal Cord Compression

time Frame

Up to 3 years.

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Preserved source evidence · Not medical advice