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NCT03277352 · OUTCOME

Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies · Source last updated 2021-07-22

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
Screening through 60 days after end of treatment, up to approximately 18 months

What was measured

A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

Analysis population: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.

Groups in this outcome

INCAGN01876 + Pembrolizumab + Epacadostat

INCAGN01876 in combination with pembrolizumab and epacadostat

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

Analysis denominator · Participants

GroupSource count
INCAGN01876 + Pembrolizumab + Epacadostat10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCAGN01876 + Pembrolizumab + Epacadostat10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
groups
  1. description
    INCAGN01876 in combination with pembrolizumab and epacadostat
    id
    OG000
    title
    INCAGN01876 + Pembrolizumab + Epacadostat
param Type
COUNT_OF_PARTICIPANTS
population Description
The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
reporting Status
POSTED
time Frame
Screening through 60 days after end of treatment, up to approximately 18 months
title
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice