TriangleNCT03430843 · OUTCOME
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
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 to Cycle 6 (21 days per cycle)
What was measured
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Analysis population: The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Groups in this outcome
Tislelizumab
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
Investigator Chosen Chemotherapy
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
| Group | Source count |
|---|---|
| Tislelizumab | 239 |
| Investigator Chosen Chemotherapy | 246 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab | 14.7 | 11.81 | Not reported | Not reported | Not reported |
| Investigator Chosen Chemotherapy | 16.3 | 13.20 | Not reported | Not reported | Not reported |
Change at Cycle 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab | -0.6 | 8.63 | Not reported | Not reported | Not reported |
| Investigator Chosen Chemotherapy | 3.0 | 12.05 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.81
- value
- 14.7
- group Id
- OG001
- spread
- 13.20
- value
- 16.3
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 8.63
- value
- -0.6
- group Id
- OG001
- spread
- 12.05
- value
- 3.0
- title
- Change at Cycle 6
- denoms
- counts
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
- dispersion Type
- Standard Deviation
- groups
- description
- Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
- id
- OG000
- title
- Tislelizumab
- description
- Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
- id
- OG001
- title
- Investigator Chosen Chemotherapy
- param Type
- MEAN
- population Description
- The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
- reporting Status
- POSTED
- time Frame
- Baseline to Cycle 6 (21 days per cycle)
- title
- HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice