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NCT03493451 · OUTCOME

Number of Participants With Adverse Events

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 3 years and 1 week

What was measured

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs

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)

Cohort 3: MF and SS

Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] 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
Cohort 3: MF and SS11

Reported measurements

At least one TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL22Not reportedNot reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL41Not reportedNot reportedNot reportedNot reported
Cohort 3: MF and SS10Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL9Not reportedNot reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL21Not reportedNot reportedNot reportedNot reported
Cohort 3: MF and SS5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        10
    title
    At least one TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        5
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      44
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs
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
  3. description
    Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] 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
    OG002
    title
    Cohort 3: MF and SS
param Type
COUNT_OF_PARTICIPANTS
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
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice