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NCT03529422 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
Other-event reporting threshold
0%

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Open-label, Single-arm

Durvalumab in combination with intensity-modulated radiotherapy (IMRT) treatments

1 / 1817 / 183 / 18

Group identifiers: EG000: Open-label, Single-arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Vascular Disorders - Other, Specify

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Ear And Labyrinth Disorders - Other, Specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Hearing Impaired
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      18
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dysphagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Esophageal Stenosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Gastroesophageal Reflux Disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Gastrointestinal Disorders - Other, Specify
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Mucositis Oral
Complete source fields
description
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    18
    description
    Durvalumab in combination with intensity-modulated radiotherapy (IMRT) treatments
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    1
    serious Num At Risk
    18
    title
    Open-label, Single-arm
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Ear And Labyrinth Disorders - Other, Specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Hearing Impaired
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      18
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dysphagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Esophageal Stenosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Gastroesophageal Reflux Disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Gastrointestinal Disorders - Other, Specify
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Mucositis Oral
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Vascular Disorders - Other, Specify
time Frame
Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)

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