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NCT03364231 · OUTCOME

Duration of Response (DOR)

Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma · Source last updated 2023-06-23

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 first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years)

What was measured

DOR is defined as the time from documentation of a response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.

Analysis population: mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. 'Overall number of participants analyzed' is the number of participants with data available for analysis.

Groups in this outcome

MZL: Umbralisib

Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

WM: Umbralisib

Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
MZL: Umbralisib3
WM: Umbralisib3

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MZL: Umbralisib21.2Not reported333Not reported
WM: Umbralisib13Not reported514Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        33
        value
        21.2
      2. group Id
        OG001
        lower Limit
        5
        upper Limit
        14
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
DOR is defined as the time from documentation of a response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
dispersion Type
Full Range
groups
  1. description
    Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    OG000
    title
    MZL: Umbralisib
  2. description
    Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    OG001
    title
    WM: Umbralisib
param Type
MEDIAN
population Description
mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. 'Overall number of participants analyzed' is the number of participants with data available for analysis.
reporting Status
POSTED
time Frame
From the first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years)
title
Duration of Response (DOR)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice