TriangleNCT02008227 · OUTCOME
OS: TC2/3 or IC2/3 Subgroup of SP
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 until death due to any cause (up to approximately 2.87 years)
What was measured
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Analysis population: TC2/3 or IC2/3 Subgroup of SP.
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 | 182 |
| Atezolizumab | 168 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel | 11.4 | Not reported | 9.3 | 12.9 | Not reported |
| Atezolizumab | 16.6 | Not reported | 13.6 | 20.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- group Description
- Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- group Description
- Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.3
- upper Limit
- 12.9
- value
- 11.4
- group Id
- OG001
- lower Limit
- 13.6
- upper Limit
- 20.1
- value
- 16.6
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 168
- units
- Participants
- description
- OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS 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
- TC2/3 or IC2/3 Subgroup of SP.
- reporting Status
- POSTED
- time Frame
- Baseline until death due to any cause (up to approximately 2.87 years)
- title
- OS: TC2/3 or IC2/3 Subgroup of SP
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice