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NCT03493451 · OUTCOME

Overall Survival (OS)

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms · 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 approximately 3 years and 1 week

What was measured

OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.

Analysis population: Safety analysis set includes all participants who received at least one dose of study drug

Groups in this outcome

Cohort 1: ENKTL

Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Cohort 2: PTCL-NOS, AITL, and ALCL

Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per 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
Cohort 1: ENKTL22
Cohort 2: PTCL-NOS, AITL, and ALCL44

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL8.8Not reported3.25NAUpper limit of confidence interval not estimable due to insufficient number of participants with events
Cohort 2: PTCL-NOS, AITL, and ALCL13.3Not reported7.6626.22Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of confidence interval not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        3.25
        upper Limit
        NA
        value
        8.8
      2. group Id
        OG001
        lower Limit
        7.66
        upper Limit
        26.22
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      44
    units
    Participants
description
OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG000
    title
    Cohort 1: ENKTL
  2. description
    Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG001
    title
    Cohort 2: PTCL-NOS, AITL, and ALCL
param Type
MEDIAN
population Description
Safety analysis set includes all participants who received at least one dose of study drug
reporting Status
POSTED
time Frame
Up to approximately 3 years and 1 week
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice