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NCT03529422 · OUTCOME

Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy

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
12 weeks

What was measured

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

Analysis population: The type of Grade 3 Adverse Events observed in 5 subjects were included.

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

Grade 3- Weight loss
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3- Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3- Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3- wrist pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3-Dysphagia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3- Lymphedema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Open-label, Single-arm1Not reportedNot reportedNot reportedNot reported
Grade 3- Odynophagia
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
    title
    Grade 3- Weight loss
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3- Mucositis oral
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3- Hypertension
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3- wrist pain
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3-Dysphagia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3- Lymphedema
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3- Odynophagia
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
To characterize the Grade 3-4 chronic toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients. 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
The type of Grade 3 Adverse Events observed in 5 subjects were included.
reporting Status
POSTED
time Frame
12 weeks
title
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice