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NCT03506373 · OUTCOME

Number of Patients Experiencing Grade 3+ Adverse Effects (AE) Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.0

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2026-05-05

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 5 years

What was measured

The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration.

Groups in this outcome

Treatment (Ixazomib Citrate, Ibrutinib)

Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\> \> Ixazomib Citrate: Given PO\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pharmacodynamic Study: Correlative studies\> \> Pharmacokinetic Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Ixazomib Citrate, Ibrutinib)21

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Ibrutinib)13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration.
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\> \> Ixazomib Citrate: Given PO\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pharmacodynamic Study: Correlative studies\> \> Pharmacokinetic Study: Correlative studies
    id
    OG000
    title
    Treatment (Ixazomib Citrate, Ibrutinib)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 5 years
title
Number of Patients Experiencing Grade 3+ Adverse Effects (AE) Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice