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NCT02511522 · ADVERSE EVENTS

Adverse events

Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases · Source last updated 2024-10-23

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
30 days
Other-event reporting threshold
5%

Only grade 2 or higher adverse events were collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radiotherapy Combined With Best Supportive Care

Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.

0 / 3319 / 3319 / 33
Best Supportive Care Alone

Patients receive only the best supportive care.

0 / 3311 / 3324 / 33

Group identifiers: EG000: Radiotherapy Combined With Best Supportive Care · EG001: Best Supportive Care Alone

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        33
      term
      Abdominal pain
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Constipation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Nausea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        33
      term
      Fatigue
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Pain
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Anorexia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        33
      term
      Back pain
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Dysgeusia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Insomnia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Dyspnea
    Complete source fields
    description
    Only grade 2 or higher adverse events were collected.
    event Groups
    1. deaths Num Affected
      19
      deaths Num At Risk
      33
      description
      Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.
      id
      EG000
      other Num Affected
      19
      other Num At Risk
      33
      serious Num Affected
      0
      serious Num At Risk
      33
      title
      Radiotherapy Combined With Best Supportive Care
    2. deaths Num Affected
      24
      deaths Num At Risk
      33
      description
      Patients receive only the best supportive care.
      id
      EG001
      other Num Affected
      11
      other Num At Risk
      33
      serious Num Affected
      0
      serious Num At Risk
      33
      title
      Best Supportive Care Alone
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        33
      term
      Abdominal pain
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Constipation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Nausea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        33
      term
      Fatigue
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Pain
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Anorexia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        33
      term
      Back pain
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Dysgeusia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        33
      term
      Insomnia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        33
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        33
      term
      Dyspnea
    time Frame
    30 days

    Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

    Preserved source evidence · Not medical advice