TriangleNCT03777657 · OUTCOME
Change From Baseline in EORTC QLQ-C30 Fatigue Score
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 and Cycles 4 and 6
What was measured
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.
Analysis population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 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 | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 465 |
| Placebo + Chemotherapy | 467 |
Reported measurements
Cycle 4
| Group | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 388 |
| Placebo + Chemotherapy | 380 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 1.75 | Not reported | -0.09 | 3.60 | Not reported |
| Placebo + Chemotherapy | 3.07 | Not reported | 1.23 | 4.91 | Not reported |
Cycle 6
| Group | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 359 |
| Placebo + Chemotherapy | 339 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 1.71 | Not reported | -0.32 | 3.75 | Not reported |
| Placebo + Chemotherapy | 4.73 | Not reported | 2.68 | 6.77 | Not reported |
Source statistical analyses
- ci Lower Limit
- -3.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.15
- estimate Comment
- Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 4
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -1.32
- ci Lower Limit
- -5.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.24
- estimate Comment
- Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -3.01
Complete source fields
- analyses
- ci Lower Limit
- -3.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.15
- estimate Comment
- Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 4
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -1.32
- ci Lower Limit
- -5.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.24
- estimate Comment
- Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 6
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- -3.01
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.09
- upper Limit
- 3.60
- value
- 1.75
- group Id
- OG001
- lower Limit
- 1.23
- upper Limit
- 4.91
- value
- 3.07
- denoms
- counts
- group Id
- OG000
- value
- 388
- group Id
- OG001
- value
- 380
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.32
- upper Limit
- 3.75
- value
- 1.71
- group Id
- OG001
- lower Limit
- 2.68
- upper Limit
- 6.77
- value
- 4.73
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 339
- units
- Participants
- title
- Cycle 6
- denoms
- counts
- group Id
- OG000
- value
- 465
- group Id
- OG001
- value
- 467
- units
- Participants
- description
- The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- 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-C30 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 EORTC QLQ-C30 Fatigue Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice