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NCT03777657 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)

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
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and Cycles 4 and 6

What was measured

EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL. Raw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL. The QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items.

Analysis population: Participants in the ITT Analysis Set who completed the EORTC QLQ-STO22 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

Index Score: Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy387
Placebo + Chemotherapy379
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-1.71Not reported-2.77-0.66Not reported
Placebo + Chemotherapy-0.61Not reported-1.660.45Not reported
Index Score: Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy358
Placebo + Chemotherapy339
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-1.84Not reported-2.95-0.74Not reported
Placebo + Chemotherapy-0.22Not reported-1.340.89Not reported
Dysphagia/Odynophagia Scale: Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy387
Placebo + Chemotherapy379
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-2.78Not reported-3.99-1.57Not reported
Placebo + Chemotherapy-1.27Not reported-2.48-0.06Not reported
Dysphagia/Odynophagia Scale: Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy358
Placebo + Chemotherapy339
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-2.79Not reported-3.93-1.64Not reported
Placebo + Chemotherapy-2.01Not reported-3.17-0.86Not reported
Pain/Discomfort Scale: Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy387
Placebo + Chemotherapy379
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-6.88Not reported-8.39-5.36Not reported
Placebo + Chemotherapy-4.64Not reported-6.16-3.13Not reported
Pain/Discomfort Scale: Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy358
Placebo + Chemotherapy339
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-5.97Not reported-7.56-4.38Not reported
Placebo + Chemotherapy-4.09Not reported-5.69-2.49Not reported
Dietary Restrictions Scale: Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy387
Placebo + Chemotherapy379
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-0.31Not reported-1.751.12Not reported
Placebo + Chemotherapy0.61Not reported-0.822.05Not reported
Dietary Restrictions Scale: Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy358
Placebo + Chemotherapy339
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-0.25Not reported-1.791.30Not reported
Placebo + Chemotherapy1.08Not reported-0.482.63Not reported
Upper Gastro-Intestinal Symptoms: Cycle 4

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy387
Placebo + Chemotherapy379
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-3.14Not reported-4.40-1.87Not reported
Placebo + Chemotherapy-1.54Not reported-2.80-0.28Not reported
Upper Gastro-Intestinal Symptoms: Cycle 6

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy358
Placebo + Chemotherapy339
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy-3.24Not reported-4.58-1.90Not reported
Placebo + Chemotherapy-1.49Not reported-2.84-0.14Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -2.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.31
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.11
  2. ci Lower Limit
    -3.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.12
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.62
  3. ci Lower Limit
    -3.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.11
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.51
  4. ci Lower Limit
    -2.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.76
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -0.77
  5. ci Lower Limit
    -4.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.20
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -2.23
  6. ci Lower Limit
    -4.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.27
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.88
  7. ci Lower Limit
    -2.85
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -0.93
  8. ci Lower Limit
    -3.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.32
  9. ci Lower Limit
    -3.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.09
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.59
  10. ci Lower Limit
    -3.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.06
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.74
Complete source fields
analyses
  1. ci Lower Limit
    -2.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.31
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.11
  2. ci Lower Limit
    -3.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.12
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.62
  3. ci Lower Limit
    -3.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.11
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.51
  4. ci Lower Limit
    -2.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.76
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -0.77
  5. ci Lower Limit
    -4.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.20
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -2.23
  6. ci Lower Limit
    -4.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.27
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.88
  7. ci Lower Limit
    -2.85
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -0.93
  8. ci Lower Limit
    -3.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.32
  9. ci Lower Limit
    -3.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.09
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.59
  10. ci Lower Limit
    -3.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.06
    estimate Comment
    Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
    group Description
    Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean Difference
    param Value
    -1.74
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.77
        upper Limit
        -0.66
        value
        -1.71
      2. group Id
        OG001
        lower Limit
        -1.66
        upper Limit
        0.45
        value
        -0.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Index Score: Cycle 4
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.95
        upper Limit
        -0.74
        value
        -1.84
      2. group Id
        OG001
        lower Limit
        -1.34
        upper Limit
        0.89
        value
        -0.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Index Score: Cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.99
        upper Limit
        -1.57
        value
        -2.78
      2. group Id
        OG001
        lower Limit
        -2.48
        upper Limit
        -0.06
        value
        -1.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Dysphagia/Odynophagia Scale: Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.93
        upper Limit
        -1.64
        value
        -2.79
      2. group Id
        OG001
        lower Limit
        -3.17
        upper Limit
        -0.86
        value
        -2.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Dysphagia/Odynophagia Scale: Cycle 6
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.39
        upper Limit
        -5.36
        value
        -6.88
      2. group Id
        OG001
        lower Limit
        -6.16
        upper Limit
        -3.13
        value
        -4.64
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Pain/Discomfort Scale: Cycle 4
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.56
        upper Limit
        -4.38
        value
        -5.97
      2. group Id
        OG001
        lower Limit
        -5.69
        upper Limit
        -2.49
        value
        -4.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Pain/Discomfort Scale: Cycle 6
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.75
        upper Limit
        1.12
        value
        -0.31
      2. group Id
        OG001
        lower Limit
        -0.82
        upper Limit
        2.05
        value
        0.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Dietary Restrictions Scale: Cycle 4
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.79
        upper Limit
        1.30
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -0.48
        upper Limit
        2.63
        value
        1.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Dietary Restrictions Scale: Cycle 6
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.40
        upper Limit
        -1.87
        value
        -3.14
      2. group Id
        OG001
        lower Limit
        -2.80
        upper Limit
        -0.28
        value
        -1.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Upper Gastro-Intestinal Symptoms: Cycle 4
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.58
        upper Limit
        -1.90
        value
        -3.24
      2. group Id
        OG001
        lower Limit
        -2.84
        upper Limit
        -0.14
        value
        -1.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Upper Gastro-Intestinal Symptoms: Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      465
    2. group Id
      OG001
      value
      467
    units
    Participants
description
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL. Raw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL. The QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items.
dispersion Type
95% Confidence Interval
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
LEAST_SQUARES_MEAN
population Description
Participants in the ITT Analysis Set who completed the EORTC QLQ-STO22 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 Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice