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NCT00743262 · ADVERSE EVENTS

Adverse events

Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis · Source last updated 2023-07-25

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 22.5 French

A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.

0 / 150 / 15Not reported / Not reported

Group identifiers: EG000: Provox Vega 22.5 French

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
        A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        15
        serious Num Affected
        0
        serious Num At Risk
        15
        title
        Provox Vega 22.5 French
      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