TriangleNCT02580058 · OUTCOME
Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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 randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
What was measured
PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.
Analysis population: The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized.
Groups in this outcome
Avelumab
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab + PLD
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
Pegylated Liposomal Doxorubicin (PLD)
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
| Group | Source count |
|---|---|
| Avelumab | 188 |
| Avelumab + PLD | 188 |
| Pegylated Liposomal Doxorubicin (PLD) | 190 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab | 1.9 | Not reported | 1.8 | 1.9 | Not reported |
| Avelumab + PLD | 3.7 | Not reported | 3.3 | 5.1 | Not reported |
| Pegylated Liposomal Doxorubicin (PLD) | 3.5 | Not reported | 2.1 | 4.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.310
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.160
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.9999
- param Type
- Hazard Ratio (HR)
- param Value
- 1.68
- statistical Comment
- 1-sided
- statistical Method
- Log Rank
- ci Lower Limit
- 0.607
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.011
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0301
- param Type
- Hazard Ratio (HR)
- param Value
- 0.78
- statistical Comment
- 1-sided
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.310
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.160
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.9999
- param Type
- Hazard Ratio (HR)
- param Value
- 1.68
- statistical Comment
- 1-sided
- statistical Method
- Log Rank
- ci Lower Limit
- 0.607
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.011
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0301
- param Type
- Hazard Ratio (HR)
- param Value
- 0.78
- statistical Comment
- 1-sided
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 1.9
- value
- 1.9
- group Id
- OG001
- lower Limit
- 3.3
- upper Limit
- 5.1
- value
- 3.7
- group Id
- OG002
- lower Limit
- 2.1
- upper Limit
- 4.0
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 188
- group Id
- OG002
- value
- 190
- units
- Participants
- description
- PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
- id
- OG000
- title
- Avelumab
- description
- Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
- id
- OG001
- title
- Avelumab + PLD
- description
- PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
- id
- OG002
- title
- Pegylated Liposomal Doxorubicin (PLD)
- param Type
- MEDIAN
- population Description
- The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
- title
- Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice