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NCT02054806 · OUTCOME

Number of Participants Who Experienced an Adverse Event (AE)

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) · Source last updated 2023-10-30

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 approximately 28 months

What was measured

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.

Analysis population: The analysis population consisted of all allocated participants who received at least one dose of study drug.

Groups in this outcome

Pembrolizumab (MK-3475) 10 mg/kg

Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Per protocol participants were presented by treatment received in the single arm study.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab (MK-3475) 10 mg/kg475

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab (MK-3475) 10 mg/kg456Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        456
denoms
  1. counts
    1. group Id
      OG000
      value
      475
    units
    Participants
description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.
groups
  1. description
    Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Per protocol participants were presented by treatment received in the single arm study.
    id
    OG000
    title
    Pembrolizumab (MK-3475) 10 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population consisted of all allocated participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Up to approximately 28 months
title
Number of Participants Who Experienced an Adverse Event (AE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice