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NCT03783442 · OUTCOME

Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2025-07-29

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
From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months.

What was measured

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement.

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

Groups in this outcome

Tislelizumab + Chemotherapy

Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.

Placebo + Chemotherapy

Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.

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

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy324
Placebo + Chemotherapy321

Reported measurements

Treatment-emergent adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy323Not reportedNot reportedNot reportedNot reported
Placebo + Chemotherapy319Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy160Not reportedNot reportedNot reportedNot reported
Placebo + Chemotherapy128Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        323
      2. group Id
        OG001
        value
        319
    title
    Treatment-emergent adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        160
      2. group Id
        OG001
        value
        128
    title
    Serious adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      324
    2. group Id
      OG001
      value
      321
    units
    Participants
description
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement.
groups
  1. description
    Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    OG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
    id
    OG001
    title
    Placebo + Chemotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months.
title
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice