TriangleNCT03189719 · OUTCOME
Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants
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, Week 18
What was measured
The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.
Analysis population: All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC QLQ-OES18 assessment were analyzed.
Groups in this outcome
Pembrolizumab + SOC
Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Placebo + SOC
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
| Group | Source count |
|---|---|
| Pembrolizumab + SOC | 366 |
| Placebo + SOC | 359 |
Reported measurements
Dysphagia subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + SOC | -3.18 | Not reported | -7.19 | 0.82 | Not reported |
| Placebo + SOC | 2.36 | Not reported | -1.77 | 6.49 | Not reported |
Pain subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + SOC | -4.78 | Not reported | -7.01 | -2.56 | Not reported |
| Placebo + SOC | -1.85 | Not reported | -4.14 | 0.45 | Not reported |
Reflux subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + SOC | -0.22 | Not reported | -2.81 | 2.36 | Not reported |
| Placebo + SOC | 0.71 | Not reported | -1.96 | 3.38 | Not reported |
Source statistical analyses
- ci Lower Limit
- -10.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.16
- group Description
- DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0436
- param Type
- Difference in LS Means
- param Value
- -5.54
- statistical Method
- constrained Longitudinal Data Analysis
- ci Lower Limit
- -5.86
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.02
- group Description
- PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0487
- param Type
- Difference in LS Means
- param Value
- -2.94
- statistical Method
- constrained Longitudinal Data Analysis
- ci Lower Limit
- -4.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.49
- group Description
- REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.5932
- param Type
- Difference in LS Means
- param Value
- -0.93
- statistical Method
- constrained Longitudinal Data Analysis
Complete source fields
- analyses
- ci Lower Limit
- -10.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.16
- group Description
- DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0436
- param Type
- Difference in LS Means
- param Value
- -5.54
- statistical Method
- constrained Longitudinal Data Analysis
- ci Lower Limit
- -5.86
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.02
- group Description
- PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0487
- param Type
- Difference in LS Means
- param Value
- -2.94
- statistical Method
- constrained Longitudinal Data Analysis
- ci Lower Limit
- -4.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.49
- group Description
- REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.5932
- param Type
- Difference in LS Means
- param Value
- -0.93
- statistical Method
- constrained Longitudinal Data Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.19
- upper Limit
- 0.82
- value
- -3.18
- group Id
- OG001
- lower Limit
- -1.77
- upper Limit
- 6.49
- value
- 2.36
- title
- Dysphagia subscale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.01
- upper Limit
- -2.56
- value
- -4.78
- group Id
- OG001
- lower Limit
- -4.14
- upper Limit
- 0.45
- value
- -1.85
- title
- Pain subscale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.81
- upper Limit
- 2.36
- value
- -0.22
- group Id
- OG001
- lower Limit
- -1.96
- upper Limit
- 3.38
- value
- 0.71
- title
- Reflux subscale
- denoms
- counts
- group Id
- OG000
- value
- 366
- group Id
- OG001
- value
- 359
- units
- Participants
- description
- The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
- id
- OG000
- title
- Pembrolizumab + SOC
- description
- Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
- id
- OG001
- title
- Placebo + SOC
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC QLQ-OES18 assessment were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 18
- title
- Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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Preserved source evidence · Not medical advice