TriangleNCT03783442 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, Cycle 6 (Week 15)
What was measured
The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems.
Analysis population: Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement.
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 | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 310 |
| Placebo + Chemotherapy | 309 |
Reported measurements
Dysphagia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | -0.5 | Not reported | -4.7 | 3.7 | Not reported |
| Placebo + Chemotherapy | -4.9 | Not reported | -9.4 | -0.5 | Not reported |
Eating
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | -0.9 | Not reported | -3.1 | 1.3 | Not reported |
| Placebo + Chemotherapy | -1.5 | Not reported | -3.8 | 0.9 | Not reported |
Reflux
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | -1.3 | Not reported | -3.2 | 0.7 | Not reported |
| Placebo + Chemotherapy | 0.2 | Not reported | -1.9 | 2.2 | Not reported |
Pain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | -5.2 | Not reported | -6.7 | -3.7 | Not reported |
| Placebo + Chemotherapy | -3.3 | Not reported | -4.9 | -1.8 | Not reported |
Index Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | -1.0 | Not reported | -2.2 | 0.3 | Not reported |
| Placebo + Chemotherapy | -0.6 | Not reported | -1.9 | 0.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.3
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Dysphagia Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1372
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 4.4
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.7
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Eating Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7130
- param Type
- LS Mean Difference
- param Value
- 0.6
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.3
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Reflux Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3001
- param Type
- LS Mean Difference
- param Value
- -1.4
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.2
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Pain Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -1.9
- ci Lower Limit
- -2.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Index Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -0.4
Complete source fields
- analyses
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.3
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Dysphagia Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1372
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 4.4
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.7
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Eating Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7130
- param Type
- LS Mean Difference
- param Value
- 0.6
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.3
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Reflux Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3001
- param Type
- LS Mean Difference
- param Value
- -1.4
- statistical Comment
- Two-sided p-value estimated from a mixed effect model
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.2
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Pain Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -1.9
- ci Lower Limit
- -2.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4
- estimate Comment
- Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 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 EORTC QLQ-OES18 Index Score at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -0.4
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.7
- upper Limit
- 3.7
- value
- -0.5
- group Id
- OG001
- lower Limit
- -9.4
- upper Limit
- -0.5
- value
- -4.9
- title
- Dysphagia
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.1
- upper Limit
- 1.3
- value
- -0.9
- group Id
- OG001
- lower Limit
- -3.8
- upper Limit
- 0.9
- value
- -1.5
- title
- Eating
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.2
- upper Limit
- 0.7
- value
- -1.3
- group Id
- OG001
- lower Limit
- -1.9
- upper Limit
- 2.2
- value
- 0.2
- title
- Reflux
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6.7
- upper Limit
- -3.7
- value
- -5.2
- group Id
- OG001
- lower Limit
- -4.9
- upper Limit
- -1.8
- value
- -3.3
- title
- Pain
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.2
- upper Limit
- 0.3
- value
- -1.0
- group Id
- OG001
- lower Limit
- -1.9
- upper Limit
- 0.7
- value
- -0.6
- title
- Index Score
- denoms
- counts
- group Id
- OG000
- value
- 310
- group Id
- OG001
- value
- 309
- units
- Participants
- description
- The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- 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
- LEAST_SQUARES_MEAN
- population Description
- Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 6 (Week 15)
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice