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NCT04231981 · OUTCOME

Safety Adverse Events (AEs)

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) · Source last updated 2025-05-29

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
From baseline until disease progression or treatment discontinuation, up to 10.3 months

What was measured

Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events \[SAEs\]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

Groups in this outcome

Interventional Arm

Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.

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

Analysis denominator · Participants

GroupSource count
Interventional Arm18

Reported measurements

Source class 1

Related AEs

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interventional Arm5Not reportedNot reportedNot reportedNot reported

Related SAEs

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interventional Arm0Not reportedNot reportedNot reportedNot reported

Related Grade 3 or 4 AEs

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interventional Arm1Not reportedNot reportedNot reportedNot reported

Safe patients from related AEs

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interventional Arm12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Related AEs
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Related SAEs
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Related Grade 3 or 4 AEs
    4. measurements
      1. group Id
        OG000
        value
        12
      title
      Safe patients from related AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events \[SAEs\]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
groups
  1. description
    Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
    id
    OG000
    title
    Interventional Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From baseline until disease progression or treatment discontinuation, up to 10.3 months
title
Safety Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice