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NCT01079832 · ADVERSE EVENTS

Adverse events

Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies · Source last updated 2013-11-28

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 while patients were receiving treatment and during 6 months of follow up.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I: CyberKnife Radiosurgery

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

3 / 5034 / 50Not reported / Not reported

Group identifiers: EG000: Arm I: CyberKnife Radiosurgery

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
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    term
    Death not associated with CTCAE term - Disease progression NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Additional adverse events associated with this hospitalization were: Grade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical)
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    term
    Bilirubin (hyperbilirubinemia)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Confusion - Brain metastasis
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    term
    Confusion

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    "Fatigue (asthenia, lethargy, malaise)"
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pain - Abdomen NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Edema: limb
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Creatinine
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pain - Back
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pain - Chest wall
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Dyspnea (shortness of breath)
Complete source fields
event Groups
  1. description
    Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    50
    serious Num Affected
    3
    serious Num At Risk
    50
    title
    Arm I: CyberKnife Radiosurgery
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    "Fatigue (asthenia, lethargy, malaise)"
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pain - Abdomen NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Edema: limb
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Creatinine
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pain - Back
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pain - Chest wall
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Dyspnea (shortness of breath)
serious Events
  1. 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
      50
    term
    Death not associated with CTCAE term - Disease progression NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Additional adverse events associated with this hospitalization were: Grade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical)
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    term
    Bilirubin (hyperbilirubinemia)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Confusion - Brain metastasis
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    term
    Confusion
time Frame
Adverse events were collected while patients were receiving treatment and during 6 months of follow up.

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Preserved source evidence · Not medical advice