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NCT04548648 · OUTCOME

Number of Different Types of Toxicity

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 3 years

What was measured

All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting and a grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Open-label, Single-arm10

Reported measurements

Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm7Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm3Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm4Not reportedNot reportedNot reportedNot reported
Nervous System Disorders - Other, Specify (Aphasia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Confusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm3Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Amnesia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm6Not reportedNot reportedNot reportedNot reported
Anxiety
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Back Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Blurred vision
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm3Not reportedNot reportedNot reportedNot reported
Dry Skin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Dry mouth
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Gait disturbance
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Abdominal Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Arthralgia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Arthritis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Bloating
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Blood And Lymphatic System Disorders - Other, Specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm4Not reportedNot reportedNot reportedNot reported
Blood Bilirubin Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Cholesterol High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Creatinine Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Dysgeusia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Dysphasia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Edema Limbs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Gastroesophageal Reflux
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
General Disorders And Administration Site Conditions - Other, Specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Generalized Muscle Weakness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Headache
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm6Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm3Not reportedNot reportedNot reportedNot reported
Hyperhidrosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Localized Edema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Memory Impairment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Metabolism And Nutrition Disorders - Other, Specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Muscle Weakness Lower Limb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other, Specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Peripheral Motor Neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Peripheral Sensory Neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Pruritus
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Rash Acneiform
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Shingles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Skin Ulceration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Thrush
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Thyroid Stimulating Hormone Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Upper Respiratory Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Urinary Tract Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Vertigo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hypoalbuminemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Lymphocyte Count Decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Nervous System Disorders - Other, Specify (Aphasia)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Confusion
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Cough
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypokalemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hyponatremia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anorexia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Constipation
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Alanine Aminotransferase Increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alkaline Phosphatase Increased
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting and a grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
groups
  1. 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
    OG000
    title
    Open-label, Single-arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
up to 3 years
title
Number of Different Types of Toxicity
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice