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NCT03430843 · OUTCOME

Objective Response Rate (ORR) 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
NUMBER
Unit
Percentage of Participants
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

ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

Analysis population: The ITT analysis set included all randomized participants

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
Tislelizumab256
Investigator Chosen Chemotherapy256

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab20.3Not reported15.625.8Not reported
Investigator Chosen Chemotherapy9.8Not reported6.414.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.6
        upper Limit
        25.8
        value
        20.3
      2. group Id
        OG001
        lower Limit
        6.4
        upper Limit
        14.1
        value
        9.8
denoms
  1. counts
    1. group Id
      OG000
      value
      256
    2. group Id
      OG001
      value
      256
    units
    Participants
description
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
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
NUMBER
population Description
The ITT analysis set included all randomized participants
reporting Status
POSTED
time Frame
Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
title
Objective Response Rate (ORR) in the ITT Analysis Set
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice