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NCT02400437 · OUTCOME

Duration of Response (DOR)

Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia · Source last updated 2020-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment start

What was measured

The duration of response is measured from the time a participant achieved a response until the date of progression.

Analysis population: All participants who achieved a response to therapy.

Groups in this outcome

Ixazomib, Dexamethasone, Rituximab

\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.

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

Analysis denominator · Participants

GroupSource count
Ixazomib, Dexamethasone, Rituximab25

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ixazomib, Dexamethasone, Rituximab33Not reported241Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        41
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
The duration of response is measured from the time a participant achieved a response until the date of progression.
dispersion Type
Full Range
groups
  1. description
    \- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.
    id
    OG000
    title
    Ixazomib, Dexamethasone, Rituximab
param Type
MEDIAN
population Description
All participants who achieved a response to therapy.
reporting Status
POSTED
time Frame
From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment start
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice