TriangleNCT02008227 · OUTCOME
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- 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
Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. 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. No new lesions.
Analysis population: The TC1/2/3 or IC1/2/3 subgroup of PP
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 | 222 |
| Atezolizumab | 241 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel | 16.2 | Not reported | 11.62 | 21.74 | Not reported |
| Atezolizumab | 17.8 | Not reported | 13.22 | 23.27 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.62
- upper Limit
- 21.74
- value
- 16.2
- group Id
- OG001
- lower Limit
- 13.22
- upper Limit
- 23.27
- value
- 17.8
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 241
- units
- Participants
- description
- Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. 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. No 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
- NUMBER
- population Description
- The TC1/2/3 or IC1/2/3 subgroup of PP
- 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
- Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice