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NCT03777657 · OUTCOME

Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma · Source last updated 2025-02-14

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 and Cycles 4 and 6

What was measured

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: Participants in the ITT Analysis Set who completed the EQ-5D-5L at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point.

Groups in this outcome

Tislelizumab + Chemotherapy

Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Placebo + Chemotherapy

Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

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 + Chemotherapy465
Placebo + Chemotherapy467

Reported measurements

Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy360
Placebo + Chemotherapy364
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy2.915.62Not reportedNot reportedNot reported
Placebo + Chemotherapy0.814.91Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy331
Placebo + Chemotherapy322
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy3.016.38Not reportedNot reportedNot reported
Placebo + Chemotherapy-0.815.17Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.62
        value
        2.9
      2. group Id
        OG001
        spread
        14.91
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        360
      2. group Id
        OG001
        value
        364
      units
      Participants
    title
    Cycle 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.38
        value
        3.0
      2. group Id
        OG001
        spread
        15.17
        value
        -0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        331
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      465
    2. group Id
      OG001
      value
      467
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Placebo + Chemotherapy
param Type
MEAN
population Description
Participants in the ITT Analysis Set who completed the EQ-5D-5L at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point.
reporting Status
POSTED
time Frame
Baseline and Cycles 4 and 6
title
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice