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NCT00422799 · OUTCOME

Time to Progression in Patients With WM

Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM) · Source last updated 2020-10-27

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
5 Years

What was measured

Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.

Analysis population: All enrolled participants.

Groups in this outcome

Bortezomib and Rituximab

bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle

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

Analysis denominator · Participants

GroupSource count
Bortezomib and Rituximab63

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bortezomib and Rituximab1.6Not reported1.15Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        5
        value
        1.6
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.
dispersion Type
95% Confidence Interval
groups
  1. description
    bortezomib and rituximab Bortezomib: Once weekly for 3 weeks Rituximab: Intravenously once a week for the first and fourth weeks of a cycle
    id
    OG000
    title
    Bortezomib and Rituximab
param Type
MEDIAN
population Description
All enrolled participants.
reporting Status
POSTED
time Frame
5 Years
title
Time to Progression in Patients With WM
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice