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NCT01344356 · ADVERSE EVENTS

Adverse events

Stereotactic Body Radiotherapy for Head and Neck Tumors · Source last updated 2020-04-10

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
5 years
Other-event reporting threshold
0%

Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Benign Tumors

Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

0 / 11 / 10 / 1
Malignant Tumors

Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

0 / 85 / 88 / 10

Group identifiers: EG000: Benign Tumors · EG001: Malignant Tumors

Serious adverse events

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

    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
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        8
      term
      Esophagitis
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Mucositis
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        8
      term
      Hoarseness
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Fatigue
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Dizziness
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Cranial Nerve Neuropathy
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Alopecia
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Musculoskeletal Pain
    Complete source fields
    description
    Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Benign Tumors
    2. deaths Num Affected
      8
      deaths Num At Risk
      10
      description
      Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
      id
      EG001
      other Num Affected
      5
      other Num At Risk
      8
      serious Num Affected
      0
      serious Num At Risk
      8
      title
      Malignant Tumors
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        8
      term
      Esophagitis
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Mucositis
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        8
      term
      Hoarseness
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Fatigue
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Dizziness
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Cranial Nerve Neuropathy
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        8
      term
      Alopecia
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        8
      term
      Musculoskeletal Pain
    time Frame
    5 years

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

    Preserved source evidence · Not medical advice