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NCT02400437 · OUTCOME

Time to Progression (TTP)

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 start of treatment to time of disease progression, assessed up to 4 years after treatment start

What was measured

Duration of time from start of treatment to time of disease progression.

Analysis population: All participants who received 1 cycle of treatment.

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, Rituximab26

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ixazomib, Dexamethasone, Rituximab33Not reported446Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        46
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Duration of time from start of treatment to time of disease 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 received 1 cycle of treatment.
reporting Status
POSTED
time Frame
From start of treatment to time of disease progression, assessed up to 4 years after treatment start
title
Time to Progression (TTP)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice