TriangleNCT01772004 · OUTCOME
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931
What was measured
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Analysis population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Groups in this outcome
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 198 |
Reported measurements
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 6 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 26 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 51 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 77 | Not reported | Not reported | Not reported | Not reported |
Non-CR/Non-PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 1 | Not reported | Not reported | Not reported | Not reported |
Non-evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Urothelial Carcinoma | 37 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Complete response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 26
- title
- Partial response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 51
- title
- Stable disease (SD)
- categories
- measurements
- group Id
- OG000
- value
- 77
- title
- Progressive disease (PD)
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Non-CR/Non-PD
- categories
- measurements
- group Id
- OG000
- value
- 37
- title
- Non-evaluable
- denoms
- counts
- group Id
- OG000
- value
- 198
- units
- Participants
- description
- Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
- groups
- description
- Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG000
- title
- Efficacy Expansion Cohort: Urothelial Carcinoma
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931
- title
- Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice