<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216214</url>
  </required_header>
  <id_info>
    <org_study_id>178-MA-1005</org_study_id>
    <nct_id>NCT02216214</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)</brief_title>
  <acronym>PILLAR</acronym>
  <official_title>A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron&#xD;
      versus placebo in the treatment of older adult subjects with OAB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2014</start_date>
  <completion_date type="Actual">January 2, 2018</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Mean Volume Voided Per Micturition</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The mean volume voided per micturition during 3 days of the 3-day micturition diary period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Barthel Index of Daily Living Score</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in PPIUS</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in OAB-q HRQL Subscale Scores</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit</measure>
    <time_frame>Baseline and Weeks 4, 8 and EOT (up to 12 weeks)</time_frame>
    <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Micturition Frequency Normalization</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Zero Incontinence Episodes Per 24 Hours</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC</measure>
    <time_frame>End of treatment (up to 12 weeks)</time_frame>
    <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)</time_frame>
    <description>Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-void Residual Volume (PVR)</measure>
    <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
    <description>PVR was assessed by ultrasonography or bladder scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">888</enrollment>
  <condition>Overactive Bladder (OAB)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirabegron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirabegron</intervention_name>
    <description>oral tablet</description>
    <arm_group_label>Mirabegron</arm_group_label>
    <other_name>YM178</other_name>
    <other_name>Myrbetriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria assessed at Visit 1 (Screening):&#xD;
&#xD;
          -  Subject is willing and able to complete the micturition diary and questionnaires&#xD;
             correctly.&#xD;
&#xD;
          -  Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency&#xD;
             with incontinence) for greater than or equal to 3 months prior to Screening.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study from the time of&#xD;
             screening until the final study visit.&#xD;
&#xD;
        Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):&#xD;
&#xD;
          -  Subject continues to meet all inclusion criteria of Visit 1.&#xD;
&#xD;
          -  Subjects must experience at least one incontinence episode in the placebo run-in&#xD;
             period based on the 3-day micturition diary.&#xD;
&#xD;
          -  Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the&#xD;
             3-day micturition diary.&#xD;
&#xD;
          -  Subject must experience an average of greater than or equal to 8 micturitions/day&#xD;
             based on the 3-day micturition diary.&#xD;
&#xD;
        Exclusion Criteria assessed at Visit 1 (Screening):&#xD;
&#xD;
          -  Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history&#xD;
             of BOO that is currently not well controlled.&#xD;
&#xD;
          -  Subject has Post-Void Residual Volume (PVR) greater than 150 mL.&#xD;
&#xD;
          -  Subject has neurogenic bladder or neurological dysfunction or injury which could&#xD;
             affect the lower urinary tract or nerve supply.&#xD;
&#xD;
          -  Subject has significant stress incontinence or mixed stress/urgency incontinence where&#xD;
             stress is the predominant factor as determined by the Investigator (for female&#xD;
             subjects confirmed by a cough provocation test). Subjects with a history of stress&#xD;
             incontinence that is currently treated (e.g. remote history of surgery for stress&#xD;
             incontinence) may be included as long as they pass cough provocation test.&#xD;
&#xD;
          -  Subject has an indwelling catheter or practices intermittent self-catheterization.&#xD;
&#xD;
          -  Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity&#xD;
             will be performed for positive leukocytes, or nitrites, or turbidity, or at the&#xD;
             investigator's discretion and will be confirmed with a culture greater than 100,000&#xD;
             cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened&#xD;
             after successful treatment of the UTI (confirmed by a laboratory result of negative&#xD;
             urine culture).&#xD;
&#xD;
          -  Subject has a chronic inflammatory condition such as interstitial cystitis, bladder&#xD;
             stones, previous pelvic radiation therapy, or previous or current malignant disease of&#xD;
             the pelvic organs (i.e., within the confines of the pelvis including the bladder and&#xD;
             rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs&#xD;
             of the lower gastrointestinal tract are not necessarily considered pelvic organs as&#xD;
             the distal ascending colon, the full transverse colon and proximal portion of the&#xD;
             descending colon are in the abdomen).&#xD;
&#xD;
          -  Subject resides in a nursing home.&#xD;
&#xD;
          -  Subject is likely to enter a hospital or nursing home due to medical instability&#xD;
             within the next 6 months in the opinion of the Investigator.&#xD;
&#xD;
          -  Subject has received intravesical injection in the past 12 months with botulinum&#xD;
             toxin, resiniferatoxin, or capsaicin.&#xD;
&#xD;
          -  Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve&#xD;
             stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).&#xD;
&#xD;
          -  Subject began or has changed a bladder training program or pelvic floor exercises less&#xD;
             than 30 days prior to Screening.&#xD;
&#xD;
          -  Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.&#xD;
&#xD;
          -  Subject has severe renal impairment defined as estimated creatinine clearance less&#xD;
             than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR,&#xD;
             Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or&#xD;
             undergoing dialysis is also not a candidate for the study.&#xD;
&#xD;
          -  Subject has severe uncontrolled hypertension, which is defined as a sitting systolic&#xD;
             blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure&#xD;
             greater than or equal to 110 mmHg.&#xD;
&#xD;
          -  Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc&#xD;
             greater than 450 msec for males, QTc greater than 470 msec for females or a known&#xD;
             history of QT prolongation.&#xD;
&#xD;
          -  Subject has a clinically significant ECG abnormality, as determined by the&#xD;
             Investigator.&#xD;
&#xD;
          -  Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater&#xD;
             than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered&#xD;
             clinically significant by the Investigator.&#xD;
&#xD;
          -  Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists,&#xD;
             or any of the inactive ingredients.&#xD;
&#xD;
          -  Subject has any clinically significant condition, which in the opinion of the&#xD;
             Investigator makes the subject unsuitable for study participation.&#xD;
&#xD;
          -  Subject has been treated with an experimental device within 28 days or received an&#xD;
             investigational agent within 28 days or 5 half-lives, whichever is longer, prior to&#xD;
             Screening.&#xD;
&#xD;
          -  Subject has a concurrent malignancy or history of any malignancy (within the past 5&#xD;
             years), except non-metastatic basal or squamous cell carcinoma of the skin that has&#xD;
             been treated successfully.&#xD;
&#xD;
          -  Subject with current history of alcohol and/or drug abuse.&#xD;
&#xD;
          -  Subject is using prohibited medications which cannot be stopped safely during the&#xD;
             period.&#xD;
&#xD;
          -  Subject has stopped, started or changed the dose of a restricted medication within the&#xD;
             last 30 days prior to Screening.&#xD;
&#xD;
          -  Subject is involved in the conduct of the study as an employee of the Astellas group,&#xD;
             third party associated with the study, or the study site team.&#xD;
&#xD;
          -  Subject has previously received mirabegron.&#xD;
&#xD;
        Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):&#xD;
&#xD;
          -  Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat&#xD;
             screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]).&#xD;
&#xD;
          -  Subject was non-compliant during 2-week placebo run-in period, defined as taking less&#xD;
             than 80% or greater than 120% of study medication.&#xD;
&#xD;
          -  Subject has any systolic blood pressure measurement &gt; 180 mmHg or diastolic blood&#xD;
             pressure measurement &gt; 110 in the 3-day diary or during the baseline visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc., Medical Affairs, Americas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site US00066</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00148</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00009</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00020</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85715</zip>
        <country>United States</country>
      </address>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00131</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00174</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00068</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00071</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00100</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00044</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00036</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00023</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00170</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00086</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00167</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00098</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US00062</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00130</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5G 0B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00074</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6J1S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00155</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 4S5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00123</name>
      <address>
        <city>Corunna</city>
        <state>Ontario</state>
        <zip>N0N1G0</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00126</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00118</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00116</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00169</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 3Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00168</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4S 1Y2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00164</name>
      <address>
        <city>Lévis</city>
        <state>Quebec</state>
        <zip>G6W 0M6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00158</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2Y 1S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00073</name>
      <address>
        <city>Point Claire</city>
        <state>Quebec</state>
        <zip>H9R4S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00106</name>
      <address>
        <city>Point Claire</city>
        <state>Quebec</state>
        <zip>H9R4S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00156</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00061</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H5N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00129</name>
      <address>
        <city>Quebec</city>
        <zip>G1S2L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site CA00160</name>
      <address>
        <city>Quebec</city>
        <zip>G1X 0B6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=301</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>November 26, 2018</results_first_submitted>
  <results_first_submitted_qc>January 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2019</results_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary Incontinence</keyword>
  <keyword>Mirabegron</keyword>
  <keyword>Overactive Bladder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirabegron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 10, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02216214/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02216214/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who were ≥ 65 years who had symptoms of overactive bladder (OAB) were enrolled in 102 centers in 2 countries (US and Canada).</recruitment_details>
      <pre_assignment_details>Eligible participants entered into a 2-week placebo run-in period. During this time, they were asked to complete a 3-day training micturition diary and in the 3 days prior to being randomized (and after, prior to each visit). Participants were randomized in a 1:1 ratio to either mirabegron or placebo, stratified by age (&lt; 75 years, ≥ 75 years).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
        <group group_id="P2">
          <title>Mirabegron</title>
          <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="443"/>
                <participants group_id="P2" count="445"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="442"/>
                <participants group_id="P2" count="445"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="400"/>
                <participants group_id="P2" count="409"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized Never Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set (SAF): consisted of all randomized participants who received at least 1 dose of double-blind study drug. Participants from one site were excluded due to critical findings observed during a GCP audit of the site.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
        <group group_id="B2">
          <title>Mirabegron</title>
          <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="442"/>
            <count group_id="B2" value="445"/>
            <count group_id="B3" value="887"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.9" spread="6"/>
                    <measurement group_id="B2" value="71.7" spread="5.5"/>
                    <measurement group_id="B3" value="71.8" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="324"/>
                    <measurement group_id="B2" value="317"/>
                    <measurement group_id="B3" value="641"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="395"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="796"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="357"/>
                    <measurement group_id="B2" value="348"/>
                    <measurement group_id="B3" value="705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="442"/>
                    <count group_id="B2" value="445"/>
                    <count group_id="B3" value="887"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt; 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="318"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="638"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Incontinence Episodes per 24 Hours</title>
          <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine.</description>
          <population>Full analysis set-incontinence (FAS-I): included all participants who took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition and at least 1 micturition post-baseline and reported at least 1 incontinence episode in the baseline diary, and with available data and excluded participants from one site.</population>
          <units>incontinence episodes/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="430"/>
                    <count group_id="B2" value="437"/>
                    <count group_id="B3" value="867"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.44" spread="3.21"/>
                    <measurement group_id="B2" value="3.45" spread="3.11"/>
                    <measurement group_id="B3" value="3.44" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Micturitions per 24 Hours</title>
          <description>A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes).</description>
          <population>The analysis population was the FAS-I, with available data.</population>
          <units>micturitions/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="430"/>
                    <count group_id="B2" value="437"/>
                    <count group_id="B3" value="867"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.5" spread="3.1"/>
                    <measurement group_id="B2" value="10.6" spread="2.4"/>
                    <measurement group_id="B3" value="10.6" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nocturia Episodes per 24 Hours</title>
          <description>A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode.</description>
          <population>The analysis population was the FAS-I, with available data.</population>
          <units>nocturia episodes/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="430"/>
                    <count group_id="B2" value="437"/>
                    <count group_id="B3" value="867"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.43" spread="0.71"/>
                    <measurement group_id="B2" value="0.45" spread="0.81"/>
                    <measurement group_id="B3" value="0.44" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urgency Episodes per 24 Hours (Grade 3-4)</title>
          <description>An urgency episode was defined as the complaint of a sudden compelling desire to pass urine, which is difficult to defer, and is graded based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 3 = Severe urgency (I could not postpone voiding, but I had to rush to the toilet in order not to wet myself) and 4 =Urgency incontinence (I leaked before arriving to the toilet).</description>
          <population>The analysis population was the FAS-I, with available data.</population>
          <units>urgency episodes/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="430"/>
                    <count group_id="B2" value="437"/>
                    <count group_id="B3" value="867"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.84" spread="3.87"/>
                    <measurement group_id="B2" value="5.88" spread="3.61"/>
                    <measurement group_id="B3" value="5.86" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours</title>
        <description>A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Particpants with available data at baseline and EOT are included in the analysis. Last observation carried forward (LOCF) was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours</title>
          <description>A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Particpants with available data at baseline and EOT are included in the analysis. Last observation carried forward (LOCF) was used for EOT.</population>
          <units>micturitions/24 hours</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="0.2"/>
                    <measurement group_id="O2" value="-2.3" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean (LSM) Mean Difference</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>-0.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours</title>
        <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours</title>
          <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>incontinence episodes/24 hours</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.45" spread="0.13"/>
                    <measurement group_id="O2" value="-2.00" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Mean Volume Voided Per Micturition</title>
        <description>The mean volume voided per micturition during 3 days of the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Mean Volume Voided Per Micturition</title>
          <description>The mean volume voided per micturition during 3 days of the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
                <count group_id="O2" value="326"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.45" spread="4.17"/>
                    <measurement group_id="O2" value="30.54" spread="3.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>stratified rank ANCOVA</method>
            <param_type>LSM Difference</param_type>
            <param_value>13.68</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.95</ci_lower_limit>
            <ci_upper_limit>22.42</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score</title>
        <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score</title>
          <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="434"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.69" spread="1.33"/>
                    <measurement group_id="O2" value="-23.39" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LSM Difference</param_type>
            <param_value>-5.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.84</ci_lower_limit>
            <ci_upper_limit>-2.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score</title>
        <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score</title>
          <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="434"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.80" spread="1.04"/>
                    <measurement group_id="O2" value="17.18" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LSM Difference</param_type>
            <param_value>2.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>4.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)</title>
        <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)</title>
          <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="428"/>
                <count group_id="O2" value="431"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.1"/>
                    <measurement group_id="O2" value="-1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>-0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours</title>
        <description>Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours</title>
          <description>Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>urgency episodes/24 hours</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.81" spread="0.21"/>
                    <measurement group_id="O2" value="-3.66" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours</title>
        <description>An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours</title>
          <description>An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>urgency incontinence episodes/24 hours</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.37" spread="0.12"/>
                    <measurement group_id="O2" value="-1.93" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and number of valid diary days as the offset variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Negative Binomial Regression Model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.68</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours</title>
        <description>A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours</title>
          <description>A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>nocturia episodes/24 hours</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.04"/>
                    <measurement group_id="O2" value="-0.29" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (&lt;75, &gt;=75 years) and country as fixed factors and number of valid diary days as the offset variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.432</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Negative Binomial Regression Model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.84</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Barthel Index of Daily Living Score</title>
        <description>The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Barthel Index of Daily Living Score</title>
          <description>The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="415"/>
                <count group_id="O2" value="420"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.1"/>
                    <measurement group_id="O2" value="0.5" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.317</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score</title>
        <description>The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score</title>
          <description>The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.1"/>
                    <measurement group_id="O2" value="-0.3" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.165</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in PPIUS</title>
        <description>The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in PPIUS</title>
          <description>The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="0.04"/>
                    <measurement group_id="O2" value="-0.54" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in OAB-q HRQL Subscale Scores</title>
        <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in OAB-q HRQL Subscale Scores</title>
          <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="434"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Coping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.36" spread="1.23"/>
                    <measurement group_id="O2" value="18.95" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Concern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.89" spread="1.19"/>
                    <measurement group_id="O2" value="19.72" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.46" spread="1.38"/>
                    <measurement group_id="O2" value="16.82" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.15" spread="0.78"/>
                    <measurement group_id="O2" value="11.47" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Coping Subscale Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Concern Subscale Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sleep Subscale Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Subscale Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.614</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)</title>
        <description>The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)</title>
          <description>The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.455" spread="2.058"/>
                    <measurement group_id="O2" value="20.110" spread="2.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)</title>
        <description>The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)</title>
          <description>The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="429"/>
                <count group_id="O2" value="433"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="1.20"/>
                    <measurement group_id="O2" value="1.14" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.755</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit</title>
        <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.</description>
        <time_frame>Baseline and Weeks 4, 8 and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at all time points are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit</title>
          <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.</description>
          <population>The analysis population was the FAS-I. Participants with available data at all time points are included in the analysis. LOCF was used for EOT.</population>
          <units>incontinence episodes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="437"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="416"/>
                    <count group_id="O2" value="427"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.03" spread="0.12"/>
                    <measurement group_id="O2" value="-1.44" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="406"/>
                    <count group_id="O2" value="404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.36" spread="0.11"/>
                    <measurement group_id="O2" value="-1.77" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="427"/>
                    <count group_id="O2" value="435"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.40" spread="0.13"/>
                    <measurement group_id="O2" value="-1.94" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (&lt;75, &gt;=75 years) and country as factors and number of valid diary days as the offset variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Negative Binomial Regression Model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (&lt;75, &gt;=75 years) and country as factors and number of valid diary days as the offset variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Negative Binomial Regression Model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (&lt;75, &gt;=75 years) and country as factors and number of valid diary days as the offset variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Negative Binomial Regression Model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit</title>
        <description>The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit</title>
          <description>The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.</description>
          <population>The analysis population was the FAS-I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Micturition Frequency Normalization</title>
        <description>Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. Non-responder imputation (NRI) was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Micturition Frequency Normalization</title>
          <description>Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. Non-responder imputation (NRI) was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="437"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0"/>
                    <measurement group_id="O2" value="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.500</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours</title>
        <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours</title>
          <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="428"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                    <measurement group_id="O2" value="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.775</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Zero Incontinence Episodes Per 24 Hours</title>
        <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Zero Incontinence Episodes Per 24 Hours</title>
          <description>An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="428"/>
                <count group_id="O2" value="435"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                    <measurement group_id="O2" value="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.501</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales</title>
        <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales</title>
          <description>The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="436"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Coping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.7"/>
                    <measurement group_id="O2" value="66.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Concern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6"/>
                    <measurement group_id="O2" value="62.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1"/>
                    <measurement group_id="O2" value="60.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1"/>
                    <measurement group_id="O2" value="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.034</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.390</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.070</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.327</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.452</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.602</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.116</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC</title>
        <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC</title>
          <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="428"/>
                <count group_id="O2" value="433"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4"/>
                    <measurement group_id="O2" value="64.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.634</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC</title>
        <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
        <time_frame>End of treatment (up to 12 weeks)</time_frame>
        <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC</title>
          <description>The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.</description>
          <population>The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="428"/>
                <count group_id="O2" value="433"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1"/>
                    <measurement group_id="O2" value="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratio: Logistic regression was performed with treatment group, sex, age group (&lt;75, &gt;=75 years), and country as fixed factors and baseline value as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.597</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.</description>
        <time_frame>From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)</time_frame>
        <population>The analysis population was the SAF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.</description>
          <population>The analysis population was the SAF.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="442"/>
                <count group_id="O2" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Leading to Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Leading to Study Drug Discont.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs Leading to Study Drug Discont.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score</title>
        <description>The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the SAF. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score</title>
          <description>The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.</description>
          <population>The analysis population was the SAF. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="411"/>
                <count group_id="O2" value="425"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.14"/>
                    <measurement group_id="O2" value="-0.16" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.471</p_value>
            <p_value_desc>P-value compares the Mirabegron group to the placebo group.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-void Residual Volume (PVR)</title>
        <description>PVR was assessed by ultrasonography or bladder scan.</description>
        <time_frame>Baseline and EOT (up to 12 weeks)</time_frame>
        <population>The analysis population was the SAF. Participants with available data are included in the analysis. LOCF was used for EOT.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Mirabegron</title>
            <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-void Residual Volume (PVR)</title>
          <description>PVR was assessed by ultrasonography or bladder scan.</description>
          <population>The analysis population was the SAF. Participants with available data are included in the analysis. LOCF was used for EOT.</population>
          <units>mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="380"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="40.3"/>
                    <measurement group_id="O2" value="2.6" spread="56.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
        <group group_id="E2">
          <title>Mirabegron</title>
          <description>Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="442"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Tonsil cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="442"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="442"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="442"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="445"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Participants from one site were excluded from the FAS-I and SAF due to critical findings observed during a GCP audit of the site.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure</name_or_title>
      <organization>Astellas Pharma Global Development, Inc.</organization>
      <phone>800-888-7704</phone>
      <email>astellas.resultsdisclosure@astellas.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216214
org study id: 178-MA-1005
nct id: NCT02216214
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron
      versus placebo in the treatment of older adult subjects with OAB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
time frame: Baseline and EOT (up to 12 weeks)
description: A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
measure: Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
time frame: Baseline and EOT (up to 12 weeks)
description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.
measure: Change From Baseline to EOT in Mean Volume Voided Per Micturition
time frame: Baseline and EOT (up to 12 weeks)
description: The mean volume voided per micturition during 3 days of the 3-day micturition diary period.
measure: Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score
time frame: Baseline and EOT (up to 12 weeks)
description: The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
measure: Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score
time frame: Baseline and EOT (up to 12 weeks)
description: The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
measure: Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)
time frame: Baseline and EOT (up to 12 weeks)
description: The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.
measure: Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
time frame: Baseline and EOT (up to 12 weeks)
description: Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.
measure: Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
time frame: Baseline and EOT (up to 12 weeks)
description: An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.
measure: Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours
time frame: Baseline and EOT (up to 12 weeks)
description: A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.
measure: Change From Baseline to EOT in Barthel Index of Daily Living Score
time frame: Baseline and EOT (up to 12 weeks)
description: The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.
measure: Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score
time frame: Baseline and EOT (up to 12 weeks)
description: The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.
measure: Change From Baseline to EOT in PPIUS
time frame: Baseline and EOT (up to 12 weeks)
description: The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.
measure: Change From Baseline to EOT in OAB-q HRQL Subscale Scores
time frame: Baseline and EOT (up to 12 weeks)
description: The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
measure: Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
time frame: Baseline and EOT (up to 12 weeks)
description: The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).
measure: Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)
time frame: Baseline and EOT (up to 12 weeks)
description: The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.
measure: Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit
time frame: Baseline and Weeks 4, 8 and EOT (up to 12 weeks)
description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.
measure: Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit
time frame: Baseline and EOT (up to 12 weeks)
description: The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.
measure: Percentage of Participants Who Achieved Micturition Frequency Normalization
time frame: End of treatment (up to 12 weeks)
description: Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.
measure: Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours
time frame: End of treatment (up to 12 weeks)
description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.
measure: Percentage of Participants With Zero Incontinence Episodes Per 24 Hours
time frame: End of treatment (up to 12 weeks)
description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.
measure: Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales
time frame: End of treatment (up to 12 weeks)
description: The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.
measure: Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC
time frame: End of treatment (up to 12 weeks)
description: The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.
measure: Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC
time frame: End of treatment (up to 12 weeks)
description: The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.
measure: Number of Participants With Adverse Events (AEs)
time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)
description: Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.
measure: Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score
time frame: Baseline and EOT (up to 12 weeks)
description: The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.
measure: Change From Baseline in Post-void Residual Volume (PVR)
time frame: Baseline and EOT (up to 12 weeks)
description: PVR was assessed by ultrasonography or bladder scan.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
arm group label: Mirabegron
arm group type: Experimental
description: Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
intervention type: Drug
intervention name: Mirabegron
description: oral tablet
arm group label: Mirabegron
other name: YM178
other name: Myrbetriq
intervention type: Drug
intervention name: Placebo
description: oral tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc., Medical Affairs, Americas
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country: Canada
country: United States
url: https://astellasclinicalstudyresults.com/study.aspx?ID=301
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Mirabegron
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: https://www.clinicalstudydatarequest.com/
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants from one site were excluded from the FAS-I and SAF due to critical findings observed during a GCP audit of the site.
point of contact: 