NCT05551117 · OUTCOME
Part 1: Mean Best Tumor Size Change Over Time
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change from baseline
- Interval / dispersion
- Standard Deviation
- Time frame
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
Analysis population: All participants with mCRPC who received at least one dose of study treatment and had RECIST-evaluable disease per PCWG3 (Tumor Response Evaluable Population) in Part 1 of the study. Participants in Part 2 of the study did not have mCRPC and are excluded from this analysis.
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) | 59 |
| Part 1: MGC018 2.7 mg (Arm B) | 49 |
| Part 1: Control Arm | 2 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | -13.0 | 59.70 | Not reported | Not reported | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | -29.0 | 33.92 | Not reported | Not reported | Not reported |
| Part 1: Control Arm | -7.44 | 7.16 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 59.70
- value
- -13.0
- group Id
- OG001
- spread
- 33.92
- value
- -29.0
- group Id
- OG002
- spread
- 7.16
- value
- -7.44
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- units
- Participants
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All participants with mCRPC who received at least one dose of study treatment and had RECIST-evaluable disease per PCWG3 (Tumor Response Evaluable Population) in Part 1 of the study. Participants in Part 2 of the study did not have mCRPC and are excluded from this analysis.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
- title
- Part 1: Mean Best Tumor Size Change Over Time
- type
- SECONDARY
- unit Of Measure
- percent change from baseline
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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