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NCT03529422 · OUTCOME

Number of Participants With Grade 3-4 Acute Toxicities

Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN · Source last updated 2026-06-23

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 30 days

What was measured

To characterize safety by evaluating Grade 3-4 acute toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients receiving adjuvant durvalumab with radiotherapy. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).

Analysis population: Participants started to study the treatment.

Groups in this outcome

Open-label, Single-arm

Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks

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

Analysis denominator · Participants

GroupSource count
Open-label, Single-arm16

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
To characterize safety by evaluating Grade 3-4 acute toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients receiving adjuvant durvalumab with radiotherapy. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
groups
  1. description
    Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
    id
    OG000
    title
    Open-label, Single-arm
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants started to study the treatment.
reporting Status
POSTED
time Frame
Up to 30 days
title
Number of Participants With Grade 3-4 Acute Toxicities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice