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NCT03174275 · ADVERSE EVENTS

Adverse events

Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma · Source last updated 2026-02-23

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 adjuvant treatment, up to 9 months.
Other-event reporting threshold
0%

CTCAEv4

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Subjects

This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, Adverse Events were reported based on the whole group.

9 / 3938 / 390 / 39

Group identifiers: EG000: All Subjects

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Endocrine disorders - Other, specify
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Dysphagia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    General disorders and administration site conditions - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Lung infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Skin infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Tracheitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Urinary tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Fracture
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Dehydration

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      39
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Blood and lymphatic system disorders other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Heart failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Mitral valve disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Sinus bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Sinus tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    External ear pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Hearing impaired
Complete source fields
description
CTCAEv4
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, Adverse Events were reported based on the whole group.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    39
    serious Num Affected
    9
    serious Num At Risk
    39
    title
    All Subjects
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      39
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Blood and lymphatic system disorders other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Heart failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Mitral valve disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Sinus bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Sinus tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    External ear pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Hearing impaired
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Endocrine disorders - Other, specify
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
    term
    Dysphagia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    General disorders and administration site conditions - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Lung infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Skin infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Tracheitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Urinary tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
    term
    Fracture
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
    term
    Dehydration
time Frame
Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months.

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