Participant flow

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.

groups

1. description

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

   id

   FG000

   title

   Placebo

2. description

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

   id

   FG001

   title

   Mirabegron 50 mg

3. description

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

   id

   FG002

   title

   Mirabegron 100 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Non-compliant with study procedures

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         70

      3. group Id

         FG002

         num Subjects

         65

      type

      STARTED

   2. achievements

      1. comment

         All patients who received at least 1 dose of double-blind study drug.

         group Id

         FG000

         num Subjects

         65

      2. comment

         All patients who received at least 1 dose of double-blind study drug.

         group Id

         FG001

         num Subjects

         70

      3. comment

         All patients who received at least 1 dose of double-blind study drug.

         group Id

         FG002

         num Subjects

         65

      type

      Safety Analysis Set (SAF)

   3. achievements

      1. comment

         SAF patients with both Qmax \& PdetQmax measurements at baseline and 1 or both measured postbaseline.

         group Id

         FG000

         num Subjects

         63

      2. comment

         SAF patients with both Qmax \& PdetQmax measurements at baseline and 1 or both measured postbaseline.

         group Id

         FG001

         num Subjects

         64

      3. comment

         SAF patients with both Qmax \& PdetQmax measurements at baseline and 1 or both measured postbaseline.

         group Id

         FG002

         num Subjects

         58

      type

      Full Analysis Set (FAS)

   4. achievements

      1. group Id

         FG000

         num Subjects

         63

      2. group Id

         FG001

         num Subjects

         67

      3. group Id

         FG002

         num Subjects

         58

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice