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NCT03552965 · ADVERSE EVENTS

Adverse events

Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC · Source last updated 2025-09-02

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
Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Margin-Based Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area. Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area

2 / 103 / 101 / 10
Robust Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue. Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

5 / 136 / 131 / 13

Group identifiers: EG000: Margin-Based Radiotherapy Planning · EG001: Robust Radiotherapy Planning

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dehydration
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      13
      num Events
      6
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Psychiatric disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Skin infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    White blood cell decreased

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      7
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Arthritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Aspartate aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Bloating
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area. Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Margin-Based Radiotherapy Planning
  2. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue. Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    13
    serious Num Affected
    5
    serious Num At Risk
    13
    title
    Robust Radiotherapy Planning
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      7
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Arthritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Aspartate aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Bloating
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dehydration
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      13
      num Events
      6
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Psychiatric disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Skin infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    White blood cell decreased
time Frame
Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

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