NCT05551117 · OUTCOME
Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.
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
- Throughout the study, average duration of participation, 10 months.
Analysis population: The Safety Population was used for 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) | 90 |
| Part 1: MGC018 2.7 mg (Arm B) | 86 |
| Part 1: Control Arm | 3 |
| Part 2 | 4 |
Reported measurements
Any Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 89 | Not reported | Not reported | Not reported | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 86 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Control Arm | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 4 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 36 | Not reported | Not reported | Not reported | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 44 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Control Arm | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Adverse Events Leading to Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 28 | Not reported | Not reported | Not reported | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 41 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Control Arm | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- title
- Any Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- Adverse Events Leading to Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- units
- Participants
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Population was used for this analysis.
- reporting Status
- POSTED
- time Frame
- Throughout the study, average duration of participation, 10 months.
- title
- Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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