Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03597295 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202) · Source last updated 2025-08-21

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
up to 913 days

What was measured

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab.

Analysis population: Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug

Groups in this outcome

Retifanlimab 500 mg

Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

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

Analysis denominator · Participants

GroupSource count
Retifanlimab 500 mg94

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Retifanlimab 500 mg90Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        90
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab.
groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
    id
    OG000
    title
    Retifanlimab 500 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
up to 913 days
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice