Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03430843 · OUTCOME

Number of Participants Experiencing Adverse Events (AEs)

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
Participants
Interval / dispersion
Not reported
Time frame
From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

What was measured

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs

Analysis population: Safety analysis set included all participants who received ≥ 1 dose of study drug

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
Tislelizumab255
Investigator Chosen Chemotherapy240

Reported measurements

Number of participants with TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tislelizumab245Not reportedNot reportedNot reportedNot reported
Investigator Chosen Chemotherapy236Not reportedNot reportedNot reportedNot reported
Number of participants with SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tislelizumab109Not reportedNot reportedNot reportedNot reported
Investigator Chosen Chemotherapy106Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        245
      2. group Id
        OG001
        value
        236
    title
    Number of participants with TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        106
    title
    Number of participants with SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      255
    2. group Id
      OG001
      value
      240
    units
    Participants
description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
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
Safety analysis set included all participants who received ≥ 1 dose of study drug
reporting Status
POSTED
time Frame
From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months
title
Number of Participants Experiencing Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice