TriangleNCT02008227 · OUTCOME
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
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 first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
What was measured
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Analysis population: The SP-ITT analysis set.
Groups in this outcome
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
| Group | Source count |
|---|---|
| Docetaxel | 72 |
| Atezolizumab | 84 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel | 6.3 | Not reported | 5.5 | 7.6 | Not reported |
| Atezolizumab | 23.9 | Not reported | 12.8 | NA | Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants. |
Source statistical analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.48
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Unstratified Hazard Ratio
- param Value
- 0.32
Complete source fields
- analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.48
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Unstratified Hazard Ratio
- param Value
- 0.32
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 7.6
- value
- 6.3
- comment
- Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.
- group Id
- OG001
- lower Limit
- 12.8
- upper Limit
- NA
- value
- 23.9
- denoms
- counts
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- id
- OG000
- title
- Docetaxel
- description
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- id
- OG001
- title
- Atezolizumab
- param Type
- MEDIAN
- population Description
- The SP-ITT analysis set.
- reporting Status
- POSTED
- time Frame
- From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
- title
- DOR as Determined by Investigator Using RECIST v1.1: SP ITT
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice