TriangleNCT02580058 · OUTCOME
PFS Based on Investigator Assessment According to 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
- month
- 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 PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.
Analysis population: The secondary efficacy endpoint was analyzed in 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 | 4.7 | Not reported | 3.7 | 6.0 | Not reported |
| Pegylated Liposomal Doxorubicin (PLD) | 3.7 | Not reported | 3.5 | 5.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 1.9
- value
- 1.9
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 6.0
- value
- 4.7
- group Id
- OG002
- lower Limit
- 3.5
- upper Limit
- 5.4
- value
- 3.7
- 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 PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.
- 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 secondary efficacy endpoint was analyzed in 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
- PFS Based on Investigator Assessment According to RECIST Version 1.1
- type
- SECONDARY
- unit Of Measure
- month
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice