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NCT02437513 · ADVERSE EVENTS

Adverse events

NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration · Source last updated 2017-08-24

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
subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NewBreez

The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. NewBreez: Intralaryngeal prosthesis to protect the airways

1 / 21 / 2Not reported / Not reported

Group identifiers: EG000: NewBreez

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
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    aspiration

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
    notes
    device failed to remain in the intended location in the larynx
    organ System
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Device migration
Complete source fields
event Groups
  1. description
    The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. NewBreez: Intralaryngeal prosthesis to protect the airways
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    NewBreez
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    device failed to remain in the intended location in the larynx
    organ System
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Device migration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    aspiration
time Frame
subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant

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

Preserved source evidence · Not medical advice