TriangleNCT01903993 · OUTCOME
PFS (Modified RECIST)
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
- From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
What was measured
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Analysis population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
Groups in this outcome
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
| Group | Source count |
|---|---|
| Atezolizumab | 144 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 4.2 | Not reported | 3.9 | 6.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- 6.9
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 144
- units
- Participants
- description
- PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
- id
- OG000
- title
- Atezolizumab
- param Type
- MEDIAN
- population Description
- ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
- reporting Status
- POSTED
- time Frame
- From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
- title
- PFS (Modified RECIST)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice