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NCT03284424 · OUTCOME

Number of Participants Who Discontinued Study Treatment Due to AE

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) · Source last updated 2024-08-23

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 56 months

What was measured

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented.

Analysis population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

Groups in this outcome

Recurrent or Metastatic Cutaneous cSCC Cohort

Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).

Locally Advanced Unresectable cSCC Cohort

Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).

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

Analysis denominator · Participants

GroupSource count
Recurrent or Metastatic Cutaneous cSCC Cohort105
Locally Advanced Unresectable cSCC Cohort54

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recurrent or Metastatic Cutaneous cSCC Cohort20Not reportedNot reportedNot reportedNot reported
Locally Advanced Unresectable cSCC Cohort11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      54
    units
    Participants
description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented.
groups
  1. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
    id
    OG000
    title
    Recurrent or Metastatic Cutaneous cSCC Cohort
  2. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
    id
    OG001
    title
    Locally Advanced Unresectable cSCC Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 56 months
title
Number of Participants Who Discontinued Study Treatment Due to AE
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice