TriangleNCT03125902 · OUTCOME
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
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
- From Day 1 to deterioration, assessed up 64 months
What was measured
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
Analysis population: PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
Groups in this outcome
Placebo and Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Placebo and Paclitaxel | 205 |
| Atezolizumab and Paclitaxel | 384 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo and Paclitaxel | 17.35 | Not reported | 9.23 | NA | Upper limit was not reached due to not sufficient number of participants with event. |
| Atezolizumab and Paclitaxel | 28.68 | Not reported | 11.99 | NA | Upper limit was not reached due to not sufficient number of participants with event. |
Source statistical analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- OTHER
- p Value
- 0.6465
- param Type
- Hazard Ratio (HR)
- param Value
- 0.94
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- OTHER
- p Value
- 0.6465
- param Type
- Hazard Ratio (HR)
- param Value
- 0.94
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit was not reached due to not sufficient number of participants with event.
- group Id
- OG000
- lower Limit
- 9.23
- upper Limit
- NA
- value
- 17.35
- comment
- Upper limit was not reached due to not sufficient number of participants with event.
- group Id
- OG001
- lower Limit
- 11.99
- upper Limit
- NA
- value
- 28.68
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 384
- units
- Participants
- description
- Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Placebo and Paclitaxel
- description
- Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Atezolizumab and Paclitaxel
- param Type
- MEDIAN
- population Description
- PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
- reporting Status
- POSTED
- time Frame
- From Day 1 to deterioration, assessed up 64 months
- title
- Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice