TriangleNCT01772004 · OUTCOME
Efficacy Expansion Cohort (Ovarian Cancer): 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
- Ovarian Cancer Efficacy Expansion: Baseline up to Day 620
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 1or 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.
Groups in this outcome
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian 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: Ovarian Cancer | 103 |
Reported measurements
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 41 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 39 | Not reported | Not reported | Not reported | Not reported |
Non-CR/Non-PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
Non-evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Complete response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Partial response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 41
- title
- Stable disease (SD)
- categories
- measurements
- group Id
- OG000
- value
- 39
- title
- Progressive disease (PD)
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Non-CR/Non-PD
- categories
- measurements
- group Id
- OG000
- value
- 16
- title
- Non-evaluable
- denoms
- counts
- group Id
- OG000
- value
- 103
- 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 1or more new lesions and unequivocal progression of non-target lesions.
- groups
- description
- Participants with ovarian 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: Ovarian Cancer
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Ovarian Cancer Efficacy Expansion: Baseline up to Day 620
- title
- Efficacy Expansion Cohort (Ovarian Cancer): 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
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice