TriangleNCT05091567 · OUTCOME
Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months
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
- Months 6 and 12
What was measured
PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.
Analysis population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
Groups in this outcome
Atezolizumab
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
Atezolizumab+ Lurbinectedin
Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
| Group | Source count |
|---|---|
| Atezolizumab | 241 |
| Atezolizumab+ Lurbinectedin | 242 |
Reported measurements
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 22.56 | 17.12 | 17.12 | 28.00 | Not reported |
| Atezolizumab+ Lurbinectedin | 46.21 | 39.60 | 39.60 | 52.81 | Not reported |
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 12.80 | 8.07 | 8.07 | 17.52 | Not reported |
| Atezolizumab+ Lurbinectedin | 20.32 | 14.33 | 14.33 | 26.32 | Not reported |
Source statistical analyses
- ci Lower Limit
- 15.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 32.20
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 23.65
- ci Lower Limit
- -0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.16
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 7.53
Complete source fields
- analyses
- ci Lower Limit
- 15.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 32.20
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 23.65
- ci Lower Limit
- -0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.16
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 7.53
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.12
- spread
- 17.12
- upper Limit
- 28.00
- value
- 22.56
- group Id
- OG001
- lower Limit
- 39.60
- spread
- 39.60
- upper Limit
- 52.81
- value
- 46.21
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.07
- spread
- 8.07
- upper Limit
- 17.52
- value
- 12.80
- group Id
- OG001
- lower Limit
- 14.33
- spread
- 14.33
- upper Limit
- 26.32
- value
- 20.32
- title
- 12 Months
- denoms
- counts
- group Id
- OG000
- value
- 241
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG000
- title
- Atezolizumab
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG001
- title
- Atezolizumab+ Lurbinectedin
- param Type
- NUMBER
- population Description
- FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
- reporting Status
- POSTED
- time Frame
- Months 6 and 12
- title
- Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice