TriangleNCT05551117 · OUTCOME
Part 1: Duration of PSA Response Per PCWG3 Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 4 weeks throughout study participation. Average duration of participation, 10 months.
What was measured
Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
Analysis population: All participants in Part 1 who met criteria for a PSA response to study treatment. There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
Groups in this outcome
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
| Group | Source count |
|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 38 |
| Part 1: MGC018 2.7 mg (Arm B) | 27 |
| Part 1: Control Arm | 0 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 6.1 | Not reported | 4.63 | NA | The upper bound of the CI could not be estimated due to insufficient number of participants with event |
| Part 1: MGC018 2.7 mg (Arm B) | NA | Not reported | 5.13 | NA | The median and upper bound of the CI could not be estimated due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper bound of the CI could not be estimated due to insufficient number of participants with event
- group Id
- OG000
- lower Limit
- 4.63
- upper Limit
- NA
- value
- 6.1
- comment
- The median and upper bound of the CI could not be estimated due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 5.13
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
- id
- OG000
- title
- Part 1: MGC018 2.0 mg (Arm A)
- description
- vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
- id
- OG001
- title
- Part 1: MGC018 2.7 mg (Arm B)
- description
- abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
- id
- OG002
- title
- Part 1: Control Arm
- description
- vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
- id
- OG003
- title
- Part 2
- param Type
- MEDIAN
- population Description
- All participants in Part 1 who met criteria for a PSA response to study treatment. There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
- reporting Status
- POSTED
- time Frame
- Every 4 weeks throughout study participation. Average duration of participation, 10 months.
- title
- Part 1: Duration of PSA Response Per PCWG3 Criteria
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice