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NCT05551117 · OUTCOME

Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors · Source last updated 2026-02-09

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: MGC018 2.0 mg (Arm A)90
Part 1: MGC018 2.7 mg (Arm B)86
Part 1: Control Arm3
Part 24

Reported measurements

Any Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)89Not reportedNot reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)86Not reportedNot reportedNot reportedNot reported
Part 1: Control Arm3Not reportedNot reportedNot reportedNot reported
Part 24Not reportedNot reportedNot reportedNot reported
Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)36Not reportedNot reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)44Not reportedNot reportedNot reportedNot reported
Part 1: Control Arm1Not reportedNot reportedNot reportedNot reported
Part 22Not reportedNot reportedNot reportedNot reported
Adverse Events Leading to Discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)28Not reportedNot reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)41Not reportedNot reportedNot reportedNot reported
Part 1: Control Arm0Not reportedNot reportedNot reportedNot reported
Part 22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        86
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
    title
    Any Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        44
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
    title
    Serious Adverse Events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
    title
    Adverse Events Leading to Discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      86
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    units
    Participants
groups
  1. description
    vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
    id
    OG000
    title
    Part 1: MGC018 2.0 mg (Arm A)
  2. description
    vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
    id
    OG001
    title
    Part 1: MGC018 2.7 mg (Arm B)
  3. description
    abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
    id
    OG002
    title
    Part 1: Control Arm
  4. 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

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Preserved source evidence · Not medical advice