TriangleNCT02580058 · OUTCOME
ORR Based on Investigator 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 achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.
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 | 5.3 | Not reported | 2.6 | 9.6 | Not reported |
| Avelumab + PLD | 18.6 | Not reported | 13.3 | 24.9 | Not reported |
| Pegylated Liposomal Doxorubicin (PLD) | 9.5 | Not reported | 5.7 | 14.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- upper Limit
- 9.6
- value
- 5.3
- group Id
- OG001
- lower Limit
- 13.3
- upper Limit
- 24.9
- value
- 18.6
- group Id
- OG002
- lower Limit
- 5.7
- upper Limit
- 14.6
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 188
- group Id
- OG002
- value
- 190
- units
- Participants
- description
- Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.
- 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
- ORR Based on Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice