TriangleNCT03125902 · OUTCOME
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
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 or death from any cause, assessed up to 12 months
What was measured
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.
Analysis population: ITT population: all randomized participants, whether or not the assigned study treatment was received
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 | 220 |
| Atezolizumab and Paclitaxel | 431 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo and Paclitaxel | 16.22 | Not reported | 10.18 | 22.26 | Not reported |
| Atezolizumab and Paclitaxel | 21.63 | Not reported | 16.74 | 26.51 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.18
- upper Limit
- 22.26
- value
- 16.22
- group Id
- OG001
- lower Limit
- 16.74
- upper Limit
- 26.51
- value
- 21.63
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 431
- units
- Participants
- description
- 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.
- 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
- ITT population: all randomized participants, whether or not the assigned study treatment was received
- reporting Status
- POSTED
- time Frame
- From Day 1 to PD or death from any cause, assessed up to 12 months
- title
- Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice