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NCT00661570 · ADVERSE EVENTS

Adverse events

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis · Source last updated 2017-03-10

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
Adverse events were recorded from the time the new Vega prosthesis was inserted until the voice prosthesis was replaced.
Other-event reporting threshold
5%

Adverse events were assessed after the insertion procedure, upon notification of a problem by the patient, and when the Provox Vega needed replacement. Normal reasons for replacement (leakage through, size changes) were not considered adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Provox Vega 20

26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.

0 / 260 / 26Not reported / Not reported

Group identifiers: EG000: Provox Vega 20

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.

      Complete source fields
      description
      Adverse events were assessed after the insertion procedure, upon notification of a problem by the patient, and when the Provox Vega needed replacement. Normal reasons for replacement (leakage through, size changes) were not considered adverse events.
      event Groups
      1. description
        26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        26
        serious Num Affected
        0
        serious Num At Risk
        26
        title
        Provox Vega 20
      frequency Threshold
      5
      time Frame
      Adverse events were recorded from the time the new Vega prosthesis was inserted until the voice prosthesis was replaced.

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

      Preserved source evidence · Not medical advice