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NCT00410514 · ADVERSE EVENTS

Adverse events

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) · Source last updated 2014-04-04

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
From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.

0 / 651 / 65Not reported / Not reported
Mirabegron 50 mg

Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.

0 / 704 / 70Not reported / Not reported
Mirabegron 100 mg

Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.

0 / 652 / 65Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Mirabegron 50 mg · EG002: Mirabegron 100 mg

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      MedDRA v9.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        70
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        65
      term
      Nasopharyngitis
    Complete source fields
    event Groups
    1. description
      Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      65
      serious Num Affected
      0
      serious Num At Risk
      65
      title
      Placebo
    2. description
      Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
      id
      EG001
      other Num Affected
      4
      other Num At Risk
      70
      serious Num Affected
      0
      serious Num At Risk
      70
      title
      Mirabegron 50 mg
    3. description
      Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
      id
      EG002
      other Num Affected
      2
      other Num At Risk
      65
      serious Num Affected
      0
      serious Num At Risk
      65
      title
      Mirabegron 100 mg
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      MedDRA v9.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        70
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        65
      term
      Nasopharyngitis
    time Frame
    From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).

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

    Preserved source evidence · Not medical advice