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NCT03206970 · OUTCOME

Duration Of Response

Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL) · Source last updated 2024-10-26

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years and 6 months

What was measured

The duration of response was defined as the time from the date that the response criteria are first met to the date that Progressive Disease was objectively documented or death (whichever occurs first). Participants who did not have disease progression were censored at their last valid assessment.

Analysis population: Safety Analysis Set: All participants who received any dose of study drug.

Groups in this outcome

Zanubrutinib

Zanubrutinib (160 mg) administered BID until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes 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
Zanubrutinib86

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ZanubrutinibNANot reported24.9NANA = Not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = Not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        24.9
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The duration of response was defined as the time from the date that the response criteria are first met to the date that Progressive Disease was objectively documented or death (whichever occurs first). Participants who did not have disease progression were censored at their last valid assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Zanubrutinib (160 mg) administered BID until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
    id
    OG000
    title
    Zanubrutinib
param Type
MEDIAN
population Description
Safety Analysis Set: All participants who received any dose of study drug.
reporting Status
POSTED
time Frame
Up to 3 years and 6 months
title
Duration Of Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice