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NCT03430843 · OUTCOME

Duration of Response (DOR) in the ITT Analysis Set

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · 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
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

What was measured

DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

Analysis population: The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis

Groups in this outcome

Tislelizumab

Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Investigator Chosen Chemotherapy

Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days

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

Analysis denominator · Participants

GroupSource count
Tislelizumab52
Investigator Chosen Chemotherapy25

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab7.1Not reported4.111.3Not reported
Investigator Chosen Chemotherapy4.0Not reported2.18.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        11.3
        value
        7.1
      2. group Id
        OG001
        lower Limit
        2.1
        upper Limit
        8.2
        value
        4.0
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      25
    units
    Participants
description
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
dispersion Type
95% Confidence Interval
groups
  1. description
    Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
    id
    OG000
    title
    Tislelizumab
  2. description
    Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
    id
    OG001
    title
    Investigator Chosen Chemotherapy
param Type
MEDIAN
population Description
The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis
reporting Status
POSTED
time Frame
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
title
Duration of Response (DOR) in the ITT Analysis Set
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice