NCT03430843 · OUTCOME

Overall Survival (OS) in the Intent-to-Treat (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: Approximately 2 years and 10 months from date of first randomization

What was measured

OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants

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

Group	Source count
Tislelizumab	256
Investigator Chosen Chemotherapy	256

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Tislelizumab	8.6	Not reported	7.5	10.4	Not reported
Investigator Chosen Chemotherapy	6.3	Not reported	5.3	7.0	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0001
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
1-sided, Log Rank Test

Complete source fields

analyses

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0001
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
1-sided, Log Rank Test

classes

categories
measurements
group Id
OG000
lower Limit
7.5
upper Limit
10.4
value
8.6
group Id
OG001
lower Limit
5.3
upper Limit
7.0
value
6.3

denoms

counts
group Id
OG000
value
256
group Id
OG001
value
256
units
Participants

description

OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants

dispersion Type

95% Confidence Interval

groups

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
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

reporting Status

POSTED

time Frame

Approximately 2 years and 10 months from date of first randomization

title

Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set

type

PRIMARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice