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NCT04608773 · ADVERSE EVENTS

Adverse events

Blinded Dry Mouth Spray Crossover Study · Source last updated 2024-02-01

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
6 weeks
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Biotene Spray

Participants who received biotene spray in either the 1st or 2nd two week trial period

0 / 1290 / 1290 / 129
Refresh Spray

Participants who received Refresh spray in either the 1st or 2nd two week trial period

0 / 1295 / 1290 / 129

Group identifiers: EG000: Biotene Spray · EG001: Refresh Spray

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.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        129
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        129
      term
      oral burning and swelling sensation
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      129
      description
      Participants who received biotene spray in either the 1st or 2nd two week trial period
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      129
      serious Num Affected
      0
      serious Num At Risk
      129
      title
      Biotene Spray
    2. deaths Num Affected
      0
      deaths Num At Risk
      129
      description
      Participants who received Refresh spray in either the 1st or 2nd two week trial period
      id
      EG001
      other Num Affected
      5
      other Num At Risk
      129
      serious Num Affected
      0
      serious Num At Risk
      129
      title
      Refresh Spray
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        129
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        129
      term
      oral burning and swelling sensation
    time Frame
    6 weeks

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

    Preserved source evidence · Not medical advice