TriangleNCT03125902 · OUTCOME
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
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
- From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
What was measured
Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
Analysis population: Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration
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 | 219 |
| Atezolizumab and Paclitaxel | 431 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo and Paclitaxel | 49.8 | Not reported | 42.96 | 56.59 | Not reported |
| Atezolizumab and Paclitaxel | 57.1 | Not reported | 52.25 | 61.80 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.96
- upper Limit
- 56.59
- value
- 49.8
- group Id
- OG001
- lower Limit
- 52.25
- upper Limit
- 61.80
- value
- 57.1
- denoms
- counts
- group Id
- OG000
- value
- 219
- group Id
- OG001
- value
- 431
- units
- Participants
- description
- Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
- 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
- NUMBER
- population Description
- Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration
- reporting Status
- POSTED
- time Frame
- From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
- title
- Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice