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NCT02759575 · OUTCOME

Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0

A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma · Source last updated 2021-03-12

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
30 days following completion of treatment for the first 6 participants

What was measured

Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants

Analysis population: These are the first six participants that completed the study.

Groups in this outcome

Pembrolizumab

Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses Radiation Therapy: 70 Gy in 35 fractions over 7 weeks Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants
groups
  1. description
    Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses Radiation Therapy: 70 Gy in 35 fractions over 7 weeks Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
    id
    OG000
    title
    Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
These are the first six participants that completed the study.
reporting Status
POSTED
time Frame
30 days following completion of treatment for the first 6 participants
title
Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice