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NCT00656305 · ADVERSE EVENTS

Adverse events

ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain · Source last updated 2020-02-05

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ExAblate Treatment Arm

ExAblate 2000: MR guided focused ultrasound

8 / 8749 / 878 / 87
ExAblate Sham Control Arm

ExAblate 2000: MR guided focused ultrasound sham

0 / 281 / 280 / 28

Group identifiers: EG000: ExAblate Treatment Arm · EG001: ExAblate Sham Control Arm

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
    notes
    8 subjects died due to cancer progression, unrelated to study procedures.
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Transient congnitive decline observed pre treatment resulting in gamma knife resection of brain metastasis.
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Hospitalization
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Surgery for fracture at ExAblate-treatment site
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Hospitalization

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Deep Vein Thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Skin burn
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Numbness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Neuropathy/leg pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      87
      num Events
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain/discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Apnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fever
Complete source fields
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    87
    description
    ExAblate 2000: MR guided focused ultrasound
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    87
    serious Num Affected
    8
    serious Num At Risk
    87
    title
    ExAblate Treatment Arm
  2. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    ExAblate 2000: MR guided focused ultrasound sham
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    28
    serious Num Affected
    0
    serious Num At Risk
    28
    title
    ExAblate Sham Control Arm
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Deep Vein Thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Skin burn
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Numbness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Neuropathy/leg pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      87
      num Events
      48
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain/discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Apnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fever
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    8 subjects died due to cancer progression, unrelated to study procedures.
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Transient congnitive decline observed pre treatment resulting in gamma knife resection of brain metastasis.
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Hospitalization
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Surgery for fracture at ExAblate-treatment site
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
    term
    Hospitalization

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Preserved source evidence · Not medical advice