TriangleNCT05091567 · OUTCOME
Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 26 months
What was measured
EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive \&social),3 symptom scales,GHS/QoL \& 6 single items.PF scale=5 questions about participants PF \& daily activities(strenuous activities,long walks,short walks,bed/chair rest \& needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level \& better QoL.TTCD for PF \& GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.
Analysis population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
Groups in this outcome
Atezolizumab
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
Atezolizumab+ Lurbinectedin
Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
| Group | Source count |
|---|---|
| Atezolizumab | 241 |
| Atezolizumab+ Lurbinectedin | 242 |
Reported measurements
TTCD for PF
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | NA | Not reported | NA | NA | Percentage and 95 %Cl was not estimable due to insufficient number of participants with events. |
| Atezolizumab+ Lurbinectedin | 15.9 | Not reported | 11.0 | NA | Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events. |
TTCD for GHS/QoL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 12.9 | Not reported | 11.6 | NA | Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events. |
| Atezolizumab+ Lurbinectedin | 10.8 | Not reported | 7.6 | NA | Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Percentage and 95 %Cl was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 11.0
- upper Limit
- NA
- value
- 15.9
- title
- TTCD for PF
- categories
- measurements
- comment
- Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 11.6
- upper Limit
- NA
- value
- 12.9
- comment
- Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 7.6
- upper Limit
- NA
- value
- 10.8
- title
- TTCD for GHS/QoL
- denoms
- counts
- group Id
- OG000
- value
- 241
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive \&social),3 symptom scales,GHS/QoL \& 6 single items.PF scale=5 questions about participants PF \& daily activities(strenuous activities,long walks,short walks,bed/chair rest \& needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level \& better QoL.TTCD for PF \& GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG000
- title
- Atezolizumab
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG001
- title
- Atezolizumab+ Lurbinectedin
- param Type
- MEDIAN
- population Description
- FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
- reporting Status
- POSTED
- time Frame
- Up to 26 months
- title
- Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice