TriangleNCT02008227 · OUTCOME
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-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
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
What was measured
PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and 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, or presence of new lesions.
Analysis population: The PP-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 | 425 |
| Atezolizumab | 425 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel | 4.0 | Not reported | 3.3 | 4.2 | Not reported |
| Atezolizumab | 2.8 | Not reported | 2.6 | 3.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- group Description
- Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4928
- param Type
- Hazard Ratio (HR)
- param Value
- 0.95
- statistical Method
- Log Rank
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3596
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- group Description
- Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4928
- param Type
- Hazard Ratio (HR)
- param Value
- 0.95
- statistical Method
- Log Rank
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3596
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.3
- upper Limit
- 4.2
- value
- 4.0
- group Id
- OG001
- lower Limit
- 2.6
- upper Limit
- 3.0
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 425
- group Id
- OG001
- value
- 425
- units
- Participants
- description
- PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and 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, or presence of new lesions.
- 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 PP-ITT analysis set.
- reporting Status
- POSTED
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
- title
- Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice