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NCT03067610 · ADVERSE EVENTS

Adverse events

Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer · Source last updated 2022-03-17

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
30 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radiation Therapy

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion

35 / 7265 / 721 / 72

Group identifiers: EG000: Radiation Therapy

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Acute Encephalopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      3
    term
    Acute kidney injury
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    acute mescenteric ischemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Allergic Reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    anemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
      num Events
      7
    term
    Anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    aspiration
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Atypical Chest Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    chills
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      72
      num Events
      8
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Delirium

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      72
    term
    abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    term
    abscess of chin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      72
    term
    Acid Reflex
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    acne vulgaris
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Acneform rash
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    agitated
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Albumin Decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    alkaline phosphate decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    alkaline phosphatase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Allergic Reaction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    Allergic rhinitis
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    72
    description
    Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction. chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
    id
    EG000
    other Num Affected
    65
    other Num At Risk
    72
    serious Num Affected
    35
    serious Num At Risk
    72
    title
    Radiation Therapy
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      72
    term
    abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    term
    abscess of chin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      72
    term
    Acid Reflex
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    acne vulgaris
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Acneform rash
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    agitated
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Albumin Decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    alkaline phosphate decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    alkaline phosphatase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Allergic Reaction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    Allergic rhinitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Acute Encephalopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      3
    term
    Acute kidney injury
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    acute mescenteric ischemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Allergic Reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    anemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
      num Events
      7
    term
    Anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    aspiration
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Atypical Chest Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    chills
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      72
      num Events
      8
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Delirium
time Frame
30 months

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Preserved source evidence · Not medical advice