NCT03430843 · OUTCOME

HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive 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: MEAN
Unit: Score on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline to Cycle 6 (21 days per cycle)

What was measured

Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Analysis population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point

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	78
Investigator Chosen Chemotherapy	59

Reported measurements

Baseline

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tislelizumab	74.1	14.84	Not reported	Not reported	Not reported
Investigator Chosen Chemotherapy	70.5	18.40	Not reported	Not reported	Not reported

Change at Cycle 6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tislelizumab	-0.5	17.59	Not reported	Not reported	Not reported
Investigator Chosen Chemotherapy	4.4	12.82	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
14.84
value
74.1
group Id
OG001
spread
18.40
value
70.5
title
Baseline
categories
measurements
group Id
OG000
spread
17.59
value
-0.5
group Id
OG001
spread
12.82
value
4.4
title
Change at Cycle 6

denoms

counts
group Id
OG000
value
78
group Id
OG001
value
59
units
Participants

description

dispersion Type

Standard Deviation

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

MEAN

population Description

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point

reporting Status

POSTED

time Frame

Baseline to Cycle 6 (21 days per cycle)

title

HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set

type

SECONDARY

unit Of Measure

Score on a scale

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

Preserved source evidence · Not medical advice