NCT02178722 · OUTCOME

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers · Source last updated 2022-02-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: Up to 54 months

Analysis population: The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Treatment groups for this population were determined according to the actual treatment the participant receives on Day 1. All safety analyses were conducted using the safety evaluable population.

Groups in this outcome

Phase 2: Epacadostat 100 mg BID

Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).

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

Analysis denominator · Participants

Group	Source count
Phase 2: Epacadostat 100 mg BID	382

Reported measurements

Treatment-Emergent Adverse Events (TEAE)

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Epacadostat 100 mg BID	100	Not reported	Not reported	Not reported	Not reported

Serious Treatment-Emergent Adverse Events

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Epacadostat 100 mg BID	51.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
100
title
Treatment-Emergent Adverse Events (TEAE)
categories
measurements
group Id
OG000
value
51.0
title
Serious Treatment-Emergent Adverse Events

denoms

counts
group Id
OG000
value
382
units
Participants

groups

description
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
id
OG000
title
Phase 2: Epacadostat 100 mg BID

param Type

NUMBER

population Description

The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Treatment groups for this population were determined according to the actual treatment the participant receives on Day 1. All safety analyses were conducted using the safety evaluable population.

reporting Status

POSTED

time Frame

Up to 54 months

title

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice