TriangleNCT02580058 · OUTCOME
Disease Control (DC) Rate Based on BICR Assessment
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
- Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
What was measured
Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.
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 | 33.0 | Not reported | 26.3 | 40.2 | Not reported |
| Avelumab + PLD | 57.4 | Not reported | 50.0 | 64.6 | Not reported |
| Pegylated Liposomal Doxorubicin (PLD) | 48.9 | Not reported | 41.6 | 56.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.3
- upper Limit
- 40.2
- value
- 33.0
- group Id
- OG001
- lower Limit
- 50.0
- upper Limit
- 64.6
- value
- 57.4
- group Id
- OG002
- lower Limit
- 41.6
- upper Limit
- 56.3
- value
- 48.9
- denoms
- counts
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 188
- group Id
- OG002
- value
- 190
- units
- Participants
- description
- Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.
- 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
- NUMBER
- population Description
- The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
- title
- Disease Control (DC) Rate Based on BICR Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice