A Study to Evaluate the Efficacy, Safety and Tolerability... | NCT01340027 | Trialant
NCT01340027
Sponsor
Astellas Pharma Europe B.V.
Status
Completed
Last Update Posted
Oct 31, 2024Actual
Enrollment
1,307Actual
Phase
Phase 2
Conditions
Urologic Diseases
Urinary Bladder Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder, Overactive
Interventions
Mirabegron
Solifenacin succinate
Placebo
Countries
Belarus
Belgium
Czechia
Denmark
Finland
France
Germany
Hungary
Italy
Netherlands
Norway
Poland
Portugal
Romania
Russia
Slovakia
Spain
Sweden
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01340027
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
178-CL-100
Secondary IDs
ID
Type
Description
Link
2010-020601-32
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
Official Title
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.
Acronym
Symphony
Organization
Astellas Pharma IncINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 29, 2011Actual
Primary Completion Date
Jun 28, 2012Actual
Completion Date
Jun 28, 2012Actual
First Submitted Date
Apr 20, 2011
First Submission Date that Met QC Criteria
Apr 20, 2011
First Posted Date
Apr 21, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 23, 2015
Results First Submitted that Met QC Criteria
Jun 23, 2015
Results First Posted Date
Jul 21, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 17, 2013
Certification/Extension First Submitted that Passed QC Review
Jun 17, 2013
Certification/Extension First Posted Date
Jun 25, 2013Estimated
Last Update Submitted Date
Oct 20, 2024
Last Update Posted Date
Oct 31, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Astellas Pharma Europe B.V.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
Detailed Description
Not provided
Conditions Module
Conditions
Urologic Diseases
Urinary Bladder Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder, Overactive
Keywords
Urinary incontinence
Overactive bladder (OAB)
Micturition
Frequency
YM178
Urgency incontinence
Urgency
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,307Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received matching placebo tablets orally once a day for 12 weeks
Drug: Placebo
Mirabegron 25 mg
Active Comparator
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Mirabegron 50 mg
Active Comparator
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Solifenacin 2.5 mg
Active Comparator
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Solifenacin 5 mg
Active Comparator
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Solifenacin 10 mg
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirabegron
Drug
oral
Mirabegron 25 mg
Mirabegron 50 mg
Solifenacin 10 mg and Mirabegron 25 mg
Solifenacin 10 mg and Mirabegron 50 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Baseline and Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Baseline and Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria at Visit 1/Screening:
Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m^2 and a total body weight between 50 and 95 kg;
Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
Inclusion Criteria at Visit 3/Baseline:
Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.
Exclusion Criteria:
Exclusion Criteria at Visit 1/Screening:
Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;
Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.
Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Subject has significant post-void residual (PVR) volume (> 150 mL);
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test);
Subject has a neurological cause for detrusor overactivity;
Subject has an indwelling catheter or practices intermittent self-catheterization;
Subject has diabetic neuropathy;
Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;
Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);
Subject is using medications intended to treat OAB or prohibited medications.
Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease);
Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
Exclusion Criteria at Visit 2/Placebo Run-In:
Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days;
Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);
Subject has serum creatinine > 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) > 3x ULN, or total bilirubin > 2x ULN, as assessed in Screening samples;
Exclusion Criteria at Visit 3/Baseline:
Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period;
Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.
See Also Links
Label
URL
Link to results on the Astellas Clinical Study Results website
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
After screening, 1658 participants entered a 2-week, single-blind, placebo run-in period. After completion of the run-in period, 1307 participants were randomly assigned to 1 of the 12 treatment arms in a 1:1:1:1:2:1:2:2:2:2:1:1 ratio.
Recruitment Details
Male and female patients with symptoms of overactive bladder (OAB; urgency, urinary frequency and/or urgency incontinence) for at least 3 months. The study was conducted at 141 sites in 20 countries in Europe.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
FG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Solifenacin 2.5 mg and Mirabegron 25 mg
Experimental
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 2.5 mg and Mirabegron 50 mg
Experimental
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 5 mg and Mirabegron 25 mg
Experimental
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 5 mg and Mirabegron 50 mg
Experimental
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 10 mg and Mirabegron 25 mg
Experimental
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 10 mg and Mirabegron 50 mg
Experimental
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Drug: Solifenacin succinate
Solifenacin 2.5 mg and Mirabegron 25 mg
Solifenacin 2.5 mg and Mirabegron 50 mg
Solifenacin 5 mg and Mirabegron 25 mg
Solifenacin 5 mg and Mirabegron 50 mg
Betmiga
Myrbetric
Myrbetriq
Betanis
YM178
Solifenacin succinate
Drug
oral
Solifenacin 10 mg
Solifenacin 10 mg and Mirabegron 25 mg
Solifenacin 10 mg and Mirabegron 50 mg
Solifenacin 2.5 mg
Solifenacin 2.5 mg and Mirabegron 25 mg
Solifenacin 2.5 mg and Mirabegron 50 mg
Solifenacin 5 mg
Solifenacin 5 mg and Mirabegron 25 mg
Solifenacin 5 mg and Mirabegron 50 mg
Vesikur
Vesicare
Placebo
Drug
oral
Placebo
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Baseline and Week 12
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Weeks 2, 4, 8 and 12
Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 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.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 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.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Baseline and Week 12
Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Baseline and Week 12
Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Baseline and Week 12
Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Baseline and Week 12
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Baseline and Week 12
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Baseline and Week 12
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Baseline and Week 12
Percentage of Participants With a Health-related Quality of Life Total Score Response
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Baseline and Week 12
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Baseline and Week 12
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Baseline and Week 12
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Baseline and Week 12
Minsk
220119
Belarus
BY37103
Minsk
223010
Belarus
BY37104
Vitebsk
210037
Belarus
BE32102
Brussels
1090
Belgium
BE32104
Edegem
2650
Belgium
BE32103
Ghent
9000
Belgium
BE32101
Leuven
3000
Belgium
CZ42005
Bohumín
73581
Czechia
CZ42003
Hradec Králové
500 02
Czechia
CZ42011
Ostrava
700 30
Czechia
CZ42006
Pilsen
301 24
Czechia
CZ42001
Prague
128 51
Czechia
CZ42007
Prague
14000
Czechia
CZ42009
Prague
15006
Czechia
CZ42010
Roudnice nad Labem
413 01
Czechia
CZ42012
Sternberk
78501
Czechia
CZ42002
Uherské Hradiště
68608
Czechia
DK45101
Aarhus N
8200
Denmark
DK45102
Herlev
2730
Denmark
DK45104
Holstebro
7500
Denmark
FI35803
Helsinki
00029
Finland
FI35804
Kouvola
45200
Finland
FI35801
Oulu
90220
Finland
FI35802
Tampere
33521
Finland
FR33104
Colmar
68024
France
FR33108
Dijon
21079
France
FR33103
Orléans
45067
France
FR33111
Paris
75651
France
FR33112
Paris
75970
France
FR33106
Toulouse
31059
France
FR33110
Tours
37044
France
DE49109
Bad Ems
56130
Germany
DE49103
Göttingen
37075
Germany
DE49117
Hagenow
19230
Germany
DE49105
Hettstedt
06333
Germany
DE49108
Leipzig
04105
Germany
DE49110
Neustadt in Sachsen
01844
Germany
DE49118
Reutlingen
72764
Germany
DE49101
Rostock
18107
Germany
DE49111
Sangerhausen
06526
Germany
DE49104
Wismar
23970
Germany
HU36108
Csongrád
6640
Hungary
HU36101
Győr
9024
Hungary
HU36106
Körmend
9900
Hungary
HU36110
Miskolc
3526
Hungary
HU36104
Sopron
9400
Hungary
HU36103
Szekszárd
7100
Hungary
HU36107
Tatabánya
2800
Hungary
IT39103
Avellino
83100
Italy
IT39101
Catanzaro
88100
Italy
IT39105
Florence
50139
Italy
IT39102
Treviglio (BG)
24047
Italy
NL31104
Amsterdam
1100 AD
Netherlands
NL31106
Maastricht
Netherlands
NL31102
Sneek
8601 ZK
Netherlands
NL31101
Winterswijk
7101 BN
Netherlands
NO47104
Elverum
2408
Norway
NO47102
Hamar
2317
Norway
PL48107
Krakow
31-530
Poland
PL48103
Lodz
90-602
Poland
PL48108
Lublin
20-954
Poland
PL48106
Piaseczno
05-500
Poland
PL48104
Puławy
24-100
Poland
PL48101
Warsaw
02-507
Poland
PL48105
Warsaw
02-929
Poland
PL48112
Więcbork
89-410
Poland
PL48111
Wroclaw
01-432
Poland
PT35102
Coimbra
3000-075
Portugal
PT35105
Coimbra
3041-801
Portugal
PT35104
Lisbon
1050-199
Portugal
PT35107
Lisbon
1649-035
Portugal
PT35110
Porto
4099-001
Portugal
PT35101
Porto
4200-319
Portugal
PT35106
Tomar
2304-909
Portugal
RO40106
Brasov
500152
Romania
RO40102
Bucharest
042122
Romania
RO40104
Bucharest
050659
Romania
RO40103
Bucharest
200642
Romania
RO40108
Bucharest
22328
Romania
RO40101
Craiova
20116
Romania
RO40105
Craiova
20116
Romania
RO40107
Sibiu
550245
Romania
RU70112
Kazan'
420012
Russia
RU70108
Moscow
105425
Russia
RU70110
Moscow
115682
Russia
RU70102
Saint Petersburg
191015
Russia
RU70103
Saint Petersburg
194178
Russia
RU70106
Saint Petersburg
197089
Russia
RU70101
Saint Petersburg
197136
Russia
RU70107
Saint Petersburg
198013
Russia
RU70109
Saint Petersburg
198103
Russia
RU70113
Ufa
450096
Russia
SK42109
Banská Bystrica
975 01
Slovakia
SK42112
Bratislava
832 63
Slovakia
SK42107
Košice
04011
Slovakia
SK42113
Malacky
90101
Slovakia
SK42104
Nitra
949 01
Slovakia
SK42105
Pieštany
921 01
Slovakia
SK42106
Piešťany
921 01
Slovakia
SK42102
Prešov
08001
Slovakia
SK42108
Trenčín
911 01
Slovakia
SK42101
Trenčín
91101
Slovakia
SK42103
Žilina
Slovakia
ES34103
Madrid
28031
Spain
ES34101
Madrid
28041
Spain
ES34109
Madrid
28046
Spain
ES34102
Madrid
28905
Spain
ES34105
Pamplona
31008
Spain
ES34104
Sant Joan d'Alacant
03550
Spain
ES34107
Seville
41014
Spain
SE46101
Gothenburg
41263
Sweden
SE46103
Karlshamn
37435
Sweden
SE46104
Malmö
21152
Sweden
SE46102
Stockholm
14186
Sweden
SE46105
Tanumshede
45781
Sweden
UA38104
Dnipro
49005
Ukraine
UA38102
Donetsk
83003
Ukraine
UA38111
Donetsk
83114
Ukraine
UA38106
Kiev
01023
Ukraine
UA38109
Kiev
04053
Ukraine
UA38107
Lviv
79044
Ukraine
UA38101
Odesa
Ukraine
UA38103
Zaporizhzhya
69600
Ukraine
GB44103
Bristol
BS10 5NB
United Kingdom
GB44108
Cambridge
CB2 2QQ
United Kingdom
GB44106
Garston
WD25 0EA
United Kingdom
GB44111
Glasgow
G20 0XA
United Kingdom
GB44104
Nantwich
CW5 5NX
United Kingdom
GB44110
Northwood
HA6 2RN
United Kingdom
GB44107
Plymouth
PL6 8DH
United Kingdom
GB44101
Reading
RG1 5AN
United Kingdom
GB44105
Sandbach
CW11 1EQ
United Kingdom
FG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
FG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
FG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
FG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
FG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
FG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
FG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
FG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
FG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
FG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
FG00081 subjects
FG00178 subjects
FG00279 subjects
FG00379 subjects
FG004156 subjects
FG00578 subjects
FG006149 subjects
FG007149 subjects
FG008144 subjects
FG009152 subjects
FG01081 subjects
FG01181 subjects
Received Treatment
FG00081 subjects
FG00178 subjects
FG00278 subjects
FG00379 subjects
FG004156 subjects
FG00578 subjects
FG006149 subjects
FG007149 subjects
FG008144 subjects
FG009152 subjects
FG01081 subjects
FG01181 subjects
COMPLETED
FG00076 subjects
FG00171 subjects
FG00275 subjects
FG00375 subjects
FG004146 subjects
FG00574 subjects
FG006142 subjects
FG007142 subjects
FG008136 subjects
FG009146 subjects
FG01079 subjects
FG01177 subjects
NOT COMPLETED
FG0005 subjects
FG0017 subjects
FG0024 subjects
FG0034 subjects
FG00410 subjects
FG0054 subjects
FG0067 subjects
FG0077 subjects
FG0088 subjects
FG0096 subjects
FG0102 subjects
FG0114 subjects
Type
Comment
Reasons
Randomized but Never Received Study Drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
FG004
Miscellaneous
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Baseline Measure data are provided for all randomized patients who took at least 1 dose of double-blind study drug (Safety Analysis Set). One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
BG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
BG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
BG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
BG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
BG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
BG006
Solifenacin 2.5 mg +Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
BG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
BG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
BG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
BG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
BG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00081
BG00177
BG00278
BG00379
BG004156
BG00578
BG006149
BG007149
BG008144
BG009153
BG01081
BG01181
BG0121306
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.6± 13.37
BG00155.2± 14.45
BG00253.4± 13.98
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00054
BG00152
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00081
BG00177
BG002
Type of Overactive Bladder (OAB)
Number
participants
Title
Denominators
Categories
Urge Incontinence
Title
Measurements
BG00014
BG00127
BG002
Duration of OAB Symptoms
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG00048.3± 38.37
BG00161.2± 68.03
BG002
Mean Number of Micturitions per 24 Hours
The average number of micturitions (urinations) a day recorded by the participant in a micturition diary for 3 days prior to the Baseline visit. Data available for 81, 76, 78, 79, 155, 78, 149, 148, 144, 152, 81 and 81 participants in each treatment arm respectively.
Mean
Standard Deviation
micturitions
Title
Denominators
Categories
Title
Measurements
BG00010.36± 2.036
BG001
Mean Volume Voided per Micturition
Recorded by the patient in a micturition diary for 3 days prior to the Baseline visit. Data available for 81, 76, 78, 79, 155, 78, 149, 148, 144, 152, 81 and 81 participants in each treatment arm respectively.
Mean
Standard Deviation
mL
Title
Denominators
Categories
Title
Measurements
BG000156.4± 52.80
BG001
Mean Number of Urgency Episodes per 24 Hours
Urgency episodes were those classified by the participant in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency (PPIUS) scale: 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. Data available for 81, 76, 78, 79, 155, 78, 149, 148, 144, 152, 81 and 81 participants in each treatment arm respectively.
Mean
Standard Deviation
urgency episodes
Title
Denominators
Categories
Title
Measurements
BG0005.26± 3.079
BG001
Mean Level of Urgency
Average of participants' ratings on the degree of associated urgency for each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 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. Data available for 81, 76, 78, 79, 155, 78, 149, 148, 144, 152, 81 and 81 participants in each treatment arm respectively.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0002.45± 0.503
BG001
Mean Number of Nocturia Episodes per 24 Hours
The average number of times a participant woke at night to urinate (excluding incontinence only episodes) recorded for 3 days prior to the Baseline visit in the patient micturition diary. Data available for 81, 76, 78, 79, 155, 78, 149, 148, 144, 152, 81 and 81 participants in each treatment arm respectively.
Mean
Standard Deviation
nocturia episodes
Title
Denominators
Categories
Title
Measurements
BG0002.19± 1.584
BG001
Mean Number of Incontinence Episodes per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) a day recorded by the participant in a micturition diary for 3 days prior to the Baseline visit. Data are reported for participants who took at least 1 dose of double-blind study medication with available primary efficacy data who reported at least 1 incontinence episode in the Baseline diary (Full Analysis Set-Incontinence): 17, 13, 18, 15, 35, 15, 35, 33, 32, 24, 24, 20 participants in each treatment arm respectively.
Mean
Standard Deviation
incontinence episodes
Title
Denominators
Categories
Title
Measurements
BG0000.95± 0.765
BG001
Mean Number of Urgency Incontinence Episodes per 24 Hours
The average number of urgency incontinence episodes (involuntary urine leakage accompanied by or immediately preceded by urgency) a day recorded by the participant in a micturition diary for 3 days prior to the Baseline visit. Data are reported for participants who took at least 1 dose of double-blind study medication with available primary efficacy data who reported at least 1 incontinence episode in the Baseline diary (Full Analysis Set-Incontinence): 17, 13, 18, 15, 35, 15, 35, 33, 32, 24, 24, and 20 participants in each treatment arm respectively.
Mean
Standard Deviation
urgency incontinence episodes
Title
Denominators
Categories
Title
Measurements
BG0000.78± 0.807
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.
Posted
Least Squares Mean
Standard Error
mL
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.0± 5.91
OG00124.9± 6.06
OG00234.5± 6.02
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.
Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.97
LS Mean Difference
0.3
Standard Error of the Mean
7.44
2-Sided
95
-14.3
14.9
Superiority or Other (legacy)
Secondary
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Full analysis set; LOCF was used.
Posted
Least Squares Mean
Standard Error
micturitions
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.
Posted
Least Squares Mean
Standard Error
incontinence episodes
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n")..
Posted
Least Squares Mean
Standard Error
mL
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n").
Posted
Least Squares Mean
Standard Error
micturitions
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
Posted
Number
percentage of participants
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n").
Posted
Least Squares Mean
Standard Error
incontinence episodes
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
Posted
Number
percentage of participants
Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
Posted
Number
percentage of participants
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Posted
Least Squares Mean
Standard Error
urgency incontinence episodes
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Secondary
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 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.
Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Posted
Least Squares Mean
Standard Error
urgency episodes
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 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.
Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Posted
Least Squares Mean
Standard Error
pads
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Posted
Least Squares Mean
Standard Error
nocturia episodes
Baseline and Weeks 2, 4, 8 and 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Percentage of Participants With a Health-related Quality of Life Total Score Response
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Number
participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Secondary
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Secondary
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Secondary
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
OG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
OG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Time Frame
Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
Description
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
0
81
16
81
EG001
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
0
77
16
77
EG002
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
2
78
21
78
EG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
1
79
19
79
EG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
0
156
48
156
EG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
1
78
33
78
EG006
Solifenacin 2.5 mg and Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
3
149
36
149
EG007
Solifenacin 2.5 mg and Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
2
149
34
149
EG008
Solifenacin 5 mg and Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
2
144
40
144
EG009
Solifenacin 5 mg and Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
2
153
39
153
EG010
Solifenacin 10 mg and Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
1
81
30
81
EG011
Solifenacin 10 mg and Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
1
81
35
81
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG0031 affected79 at risk
EG004
Dysphagia
Gastrointestinal disorders
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Trigeminal nerve disorder
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Fibrosis
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Foreign body trauma
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (12.1)
Systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0021 affected78 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0020 affected78 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0021 affected78 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dry mouth
Gastrointestinal disorders
MedDRA (12.1)
Systematic Assessment
EG0003 affected81 at risk
EG0012 affected77 at risk
EG0024 affected78 at risk
EG0036 affected79 at risk
EG00418 affected156 at risk
EG00523 affected78 at risk
EG00619 affected149 at risk
EG00713 affected149 at risk
EG00821 affected144 at risk
EG00920 affected153 at risk
EG01016 affected81 at risk
EG01114 affected81 at risk
Constipation
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected81 at risk
EG0010 affected77 at risk
EG0023 affected78 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected81 at risk
EG0015 affected77 at risk
EG0025 affected78 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected81 at risk
EG0011 affected77 at risk
EG0022 affected78 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected81 at risk
EG0011 affected77 at risk
EG0022 affected78 at risk
EG003
Hypertension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0007 affected81 at risk
EG0019 affected77 at risk
EG00211 affected78 at risk
EG003
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 at least 90 days prior to publication for review and comment.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Astellas Pharma Europe, B.V.
Astellas.resultsdisclosure@astellas.com
ID
Term
D014570
Urologic Diseases
D001745
Urinary Bladder Diseases
D020924
Urological Manifestations
D012816
Signs and Symptoms
D053201
Urinary Bladder, Overactive
D014549
Urinary Incontinence
Ancestor Terms
ID
Term
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D013568
Pathological Conditions, Signs and Symptoms
D059411
Lower Urinary Tract Symptoms
D014555
Urination Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C520025
mirabegron
D000069464
Solifenacin Succinate
Ancestor Terms
ID
Term
D011812
Quinuclidines
D006572
Heterocyclic Compounds, Bridged-Ring
D006571
Heterocyclic Compounds
D044005
Tetrahydroisoquinolines
D007546
Isoquinolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0062 subjects
FG0071 subjects
FG0084 subjects
FG0091 subjects
FG0101 subjects
FG0113 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
6 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
3 subjects
FG0052 subjects
FG0063 subjects
FG0074 subjects
FG0081 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
56.1
± 11.71
BG00454.2± 15.53
BG00555.0± 12.82
BG00655.8± 13.82
BG00753.7± 14.55
BG00855.0± 14.57
BG00954.1± 14.09
BG01056.5± 12.34
BG01155.5± 13.82
BG01254.8± 13.97
52
BG00351
BG004103
BG00553
BG006100
BG007100
BG00895
BG009101
BG01052
BG01154
BG012867
Male
BG00027
BG00125
BG00226
BG00328
BG00453
BG00525
BG00649
BG00749
BG00849
BG00952
BG01029
BG01127
BG012439
78
BG00378
BG004156
BG00577
BG006149
BG007148
BG008143
BG009153
BG01081
BG01181
BG0121302
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0122
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0122
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
19
BG00318
BG00439
BG00519
BG00642
BG00733
BG00835
BG00935
BG01023
BG01120
BG012324
Mixed
Title
Measurements
BG0009
BG00110
BG00210
BG00310
BG00427
BG00511
BG00622
BG00720
BG00819
BG00918
BG01014
BG01110
BG012180
Frequency
Title
Measurements
BG00056
BG00139
BG00248
BG00350
BG00489
BG00548
BG00684
BG00795
BG00890
BG009100
BG01044
BG01150
BG012793
Missing
Title
Measurements
BG0002
BG0011
BG0021
BG0031
BG0041
BG0050
BG0061
BG0071
BG0080
BG0090
BG0100
BG0111
BG0129
56.9
± 66.62
BG00360.2± 67.85
BG00461.8± 78.21
BG00552.4± 56.98
BG00657.7± 68.91
BG00757.0± 66.85
BG00856.3± 84.78
BG00957.4± 81.53
BG01064.9± 100.57
BG01157.4± 80.12
BG01257.8± 73.82
11.29
± 2.581
BG00210.78± 2.254
BG00311.10± 3.056
BG00411.34± 3.158
BG00511.29± 2.896
BG00611.25± 3.643
BG00711.00± 2.260
BG00810.92± 2.386
BG00911.25± 3.171
BG01011.14± 2.268
BG01111.24± 2.453
BG01211.10± 2.794
152.7
± 56.70
BG002156.8± 52.33
BG003162.4± 57.59
BG004145.5± 59.34
BG005148.0± 52.74
BG006156.8± 61.97
BG007149.8± 50.05
BG008155.0± 55.55
BG009153.1± 51.88
BG010141.4± 51.29
BG011155.3± 62.13
BG012152.5± 55.65
6.25
± 3.332
BG0026.58± 3.981
BG0036.20± 3.870
BG0046.41± 4.154
BG0056.37± 4.530
BG0066.05± 3.749
BG0076.78± 3.419
BG0086.26± 3.928
BG0096.49± 4.238
BG0106.91± 4.319
BG0116.81± 4.312
BG0126.37± 3.931
2.53
± 0.439
BG0022.55± 0.508
BG0032.53± 0.539
BG0042.49± 0.508
BG0052.48± 0.503
BG0062.49± 0.445
BG0072.59± 0.446
BG0082.50± 0.491
BG0092.51± 0.441
BG0102.57± 0.493
BG0112.53± 0.473
BG0122.52± 0.479
2.18
± 1.392
BG0022.31± 1.517
BG0032.46± 1.852
BG0042.19± 1.399
BG0052.50± 1.859
BG0062.64± 2.259
BG0072.05± 1.219
BG0082.28± 1.449
BG0092.27± 1.305
BG0102.65± 2.525
BG0112.41± 2.001
BG0122.33± 1.701
1.87
± 1.578
BG0021.26± 1.000
BG0031.80± 1.167
BG0041.33± 1.242
BG0051.40± 1.280
BG0061.27± 1.096
BG0071.14± 0.791
BG0081.24± 1.108
BG0091.17± 1.196
BG0101.53± 1.235
BG0111.25± 0.858
BG0121.31± 1.109
1.54
± 1.337
BG0021.19± 1.043
BG0031.56± 1.052
BG0041.32± 1.227
BG0051.18± 1.308
BG0060.96± 0.903
BG0071.06± 0.757
BG0081.23± 1.118
BG0091.08± 1.193
BG0101.51± 1.247
BG0111.20± 0.901
BG0121.20± 1.072
77
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
36.4
± 6.02
OG00436.0± 4.32
OG00536.2± 6.06
OG00639.4± 4.37
OG00741.9± 4.36
OG00853.6± 4.45
OG00954.2± 4.31
OG01057.6± 5.99
OG01162.3± 5.90
OG004
OG006
ANCOVA
0.58
LS Mean Difference
3.4
Standard Error of the Mean
6.15
2-Sided
95
-8.6
15.5
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.33
LS Mean Difference
5.9
Standard Error of the Mean
6.13
2-Sided
95
-6.1
18.0
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.005
LS Mean Difference
17.6
Standard Error of the Mean
6.20
2-Sided
95
5.4
29.8
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.003
LS Mean Difference
18.2
Standard Error of the Mean
6.10
2-Sided
95
6.2
30.2
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.003
LS Mean Difference
21.7
Standard Error of the Mean
7.37
2-Sided
95
7.2
36.1
Superiority or Other (legacy)
OG004
OG011
ANCOVA
<0.001
LS Mean Difference
26.3
Standard Error of the Mean
7.32
2-Sided
95
11.9
40.7
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.20
LS Mean Difference
11.0
Standard Error of the Mean
8.46
2-Sided
95
-5.6
27.6
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.015
LS Mean Difference
20.5
Standard Error of the Mean
8.43
2-Sided
95
4.0
37.1
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.008
LS Mean Difference
22.4
Standard Error of the Mean
8.43
2-Sided
95
5.9
39.0
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.003
LS Mean Difference
22.0
Standard Error of the Mean
7.32
2-Sided
95
7.6
36.3
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.009
LS Mean Difference
22.2
Standard Error of the Mean
8.46
2-Sided
95
5.6
38.8
Superiority or Other (legacy)
OG000
OG006
ANCOVA
<0.001
LS Mean Difference
25.4
Standard Error of the Mean
7.35
2-Sided
95
11.0
39.8
Superiority or Other (legacy)
OG000
OG007
ANCOVA
<0.001
LS Mean Difference
27.9
Standard Error of the Mean
7.34
2-Sided
95
13.5
42.3
Superiority or Other (legacy)
OG000
OG008
ANCOVA
<0.001
LS Mean Difference
39.6
Standard Error of the Mean
7.39
2-Sided
95
25.1
54.1
Superiority or Other (legacy)
OG000
OG009
ANCOVA
<0.001
LS Mean DIfference
40.2
Standard Error of the Mean
7.31
2-Sided
95
25.8
54.5
Superiority or Other (legacy)
OG000
OG010
ANCOVA
<0.001
LS Mean Difference
43.6
Standard Error of the Mean
8.42
2-Sided
95
27.1
60.1
Superiority or Other (legacy)
OG000
OG011
ANCOVA
<0.001
LS Mean Difference
48.3
Standard Error of the Mean
8.35
2-Sided
95
31.9
64.7
Superiority or Other (legacy)
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
Title
Measurements
OG000-2.43± 0.291
OG001-2.48± 0.298
OG002-2.56± 0.296
OG003-2.44± 0.296
OG004-2.54± 0.212
OG005-3.22± 0.298
OG006-2.58± 0.215
OG007-2.93± 0.215
OG008-2.56± 0.219
OG009-3.34± 0.212
OG010-3.42± 0.294
OG011-3.52± 0.291
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.062
LS Mean Difference
-0.68
Standard Error of the Mean
0.366
2-Sided
95
-1.40
0.03
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.91
LS Mean Difference
-0.04
Standard Error of the Mean
0.302
2-Sided
95
-0.63
0.56
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.20
LS Mean Difference
-0.39
Standard Error of the Mean
0.302
2-Sided
95
-0.98
0.20
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.96
LS Mean Difference
-0.02
Standard Error of the Mean
0.305
2-Sided
95
-0.62
0.58
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.007
LS Mean Difference
-0.80
Standard Error of the Mean
0.300
2-Sided
95
-1.39
-0.22
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.016
LS Mean Difference
-0.88
Standard Error of the Mean
0.363
2-Sided
95
-1.59
-0.16
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.007
LS Mean Difference
-0.98
Standard Error of the Mean
0.360
2-Sided
95
-1.68
-0.27
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.91
LS Mean Difference
-0.05
Standard Error of the Mean
0.417
2-Sided
95
-0.87
0.77
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.76
LS Mean Difference
-0.13
Standard Error of the Mean
0.415
2-Sided
95
-0.94
0.69
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.99
LS Mean Difference
-0.01
Standard Error of the Mean
0.416
2-Sided
95
-0.82
0.81
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.77
LS Mean Difference
-0.11
Standard Error of the Mean
0.361
2-Sided
95
-0.82
0.60
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.058
LS Mean Difference
-0.79
Standard Error of the Mean
0.417
2-Sided
95
-1.61
0.03
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.69
LS Mean Difference
-0.14
Standard Error of the Mean
0.362
2-Sided
95
-0.85
0.57
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.17
LS Mean Difference
-0.50
Standard Error of the Mean
0.362
2-Sided
95
-1.21
0.21
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.73
LS Mean Difference
-0.12
Standard Error of the Mean
0.364
2-Sided
95
-0.84
0.59
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.012
LS Mean Difference
-0.91
Standard Error of the Mean
0.361
2-Sided
95
-1.62
-0.20
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.018
LS Mean Difference
-0.98
Standard Error of the Mean
0.414
2-Sided
95
-1.80
-0.17
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.009
LS Mean Difference
-1.08
Standard Error of the Mean
0.412
2-Sided
95
-1.89
-0.28
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00017
OG00113
OG00218
OG00315
OG00435
OG00515
OG00635
OG00733
OG00832
OG00924
OG01024
OG01120
Title
Denominators
Categories
Title
Measurements
OG000-0.95± 0.365
OG001-0.74± 0.415
OG002-0.90± 0.353
OG003-1.26± 0.386
OG004-0.88± 0.252
OG005-0.97± 0.386
OG006-0.75± 0.251
OG007-0.85± 0.260
OG008-1.22± 0.266
OG009-1.14± 0.306
OG010-0.27± 0.304
OG011-0.97± 0.333
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.
Stratified Rank ANCOVA
P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.
0.51
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
LS Mean Difference
-0.09
Standard Error of the Mean
0.460
2-Sided
95
-1.00
0.82
Superiority or Other (legacy)
OG004
OG006
Stratified Rank ANCOVA
0.21
LS Mean Difference
0.13
Standard Error of the Mean
0.355
2-Sided
95
-0.57
0.83
Superiority or Other (legacy)
OG004
OG007
Stratified Rank ANCOVA
0.89
LS Mean Difference
0.03
Standard Error of the Mean
0.361
2-Sided
95
-0.68
0.74
Superiority or Other (legacy)
OG004
OG008
Stratified Rank ANCOVA
0.001
P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.
LS Mean Difference
-0.34
Standard Error of the Mean
0.365
2-Sided
95
-1.06
0.38
Superiority or Other (legacy)
OG004
OG009
Stratified Rank ANCOVA
0.058
LS Mean Difference
-0.26
Standard Error of the Mean
0.397
2-Sided
95
-1.04
0.52
Superiority or Other (legacy)
OG004
OG010
Stratified Rank ANCOVA
0.15
LS Mean Difference
0.60
Standard Error of the Mean
0.395
2-Sided
95
-0.17
1.38
Superiority or Other (legacy)
OG004
OG011
Stratified Rank ANCOVA
0.41
LS Mean Difference
-0.09
Standard Error of the Mean
0.417
2-Sided
95
-0.91
0.73
Superiority or Other (legacy)
OG000
OG001
Stratified Rank ANCOVA
0.44
LS Mean Difference
0.21
Standard Error of the Mean
0.554
2-Sided
95
-0.88
1.30
Superiority or Other (legacy)
OG000
OG002
Stratified Rank ANCOVA
0.85
LS Mean Difference
0.05
Standard Error of the Mean
0.505
2-Sided
95
-0.95
1.04
Superiority or Other (legacy)
OG000
OG003
Stratified Rank ANCOVA
0.83
LS Mean Difference
-0.31
Standard Error of the Mean
0.533
2-Sided
95
-1.36
0.74
Superiority or Other (legacy)
OG000
OG004
Stratified Rank ANCOVA
0.56
LS Mean Difference
0.07
Standard Error of the Mean
0.444
2-Sided
95
-0.80
0.95
Superiority or Other (legacy)
OG000
OG005
Stratified Rank ANCOVA
0.48
LS Mean Difference
-0.02
Standard Error of the Mean
0.534
2-Sided
95
-1.07
1.03
Superiority or Other (legacy)
OG000
OG006
Stratified Rank ANCOVA
0.13
LS Mean Difference
0.20
Standard Error of the Mean
0.443
2-Sided
95
-0.67
1.07
Superiority or Other (legacy)
OG000
OG007
Stratified Rank ANCOVA
0.62
LS Mean Difference
0.10
Standard Error of the Mean
0.448
2-Sided
2
-0.78
0.99
Superiority or Other (legacy)
OG000
OG008
Stratified Rank ANCOVA
0.34
LS Mean Difference
-0.27
Standard Error of the Mean
0.454
2-Sided
95
-1.16
0.63
Superiority or Other (legacy)
OG000
OG009
Stratified Rank ANCOVA
0.24
LS Mean Difference
-0.19
Standard Error of the Mean
0.472
2-Sided
95
-1.12
0.74
Superiority or Other (legacy)
OG000
OG010
Stratified Rank ANCOVA
0.88
LS Mean Difference
0.68
Standard Error of the Mean
0.475
2-Sided
95
-0.26
1.61
Superiority or Other (legacy)
OG000
OG011
Stratified Rank ANCOVA
0.83
LS Mean Difference
-0.02
Standard Error of the Mean
0.494
2-Sided
95
-0.99
0.95
Superiority or Other (legacy)
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.42
Odds Ratio (OR)
1.29
2-Sided
95
0.69
2.39
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.48
Odds Ratio (OR)
1.20
2-Sided
95
0.72
2.00
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.69
Odds Ratio (OR)
1.11
2-Sided
95
0.67
1.83
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.95
Odds Ratio (OR)
1.02
2-Sided
95
0.61
1.69
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.015
Odds Ratio (OR)
1.91
2-Sided
95
1.14
3.21
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.023
Odds Ratio (OR)
2.06
2-Sided
95
1.11
3.84
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.16
Odds Ratio (OR)
1.54
2-Sided
95
0.84
2.84
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.73
Odds Ratio (OR)
0.89
2-Sided
95
0.45
1.76
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.70
Odds Ratio (OR)
0.88
2-Sided
95
0.45
1.72
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.26
Odds Ratio (OR)
1.49
2-Sided
95
0.74
2.99
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.69
Odds Ratio (OR)
1.13
2-Sided
95
0.63
2.04
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.29
Odds Ratio (OR)
1.45
2-Sided
95
0.73
2.89
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.31
Odds Ratio (OR)
1.36
2-Sided
95
0.75
2.45
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.45
Odds Ratio (OR)
1.25
2-Sided
95
0.70
2.25
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.64
Odds Ratio (OR)
1.15
2-Sided
95
0.64
2.07
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.013
Odds Ratio (OR)
2.16
2-Sided
95
1.18
3.94
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.017
Odds Ratio (OR)
2.33
2-Sided
95
1.16
4.66
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.11
Odds Ratio (OR)
1.74
2-Sided
95
0.88
3.45
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00017
OG00113
OG00218
OG00315
OG00435
OG00515
OG00635
OG00733
OG00832
OG00924
OG01024
OG01119
Title
Denominators
Categories
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
Title
Measurements
OG000-0.83± 0.168
OG001-0.43± 0.191
OG002-0.85± 0.162
OG003-0.98± 0.178
OG004-0.67± 0.119
OG005-0.71± 0.184
OG006-0.49± 0.116
OG007-0.64± 0.120
OG008-0.70± 0.122
OG009-0.65± 0.150
OG010-1.14± 0.140
OG011-0.77± 0.157
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
Title
Measurements
OG000-0.87± 0.146
OG001-0.48± 0.189
OG002-0.89± 0.141
OG003
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
Title
Measurements
OG000-0.82± 0.163
OG001-0.65± 0.210
OG002-0.92± 0.157
OG003
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
Title
Measurements
OG000-0.93± 0.373
OG001-0.59± 0.482
OG002-0.89± 0.361
OG003
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00017
OG00113
OG00218
OG00315
OG00435
OG00515
OG00635
OG00733
OG00832
OG00924
OG01024
OG01120
Title
Denominators
Categories
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
Title
Measurements
OG00047.1
OG00123.1
OG00244.4
OG00340.0
OG00445.5
OG00550.0
OG00640.0
OG00751.5
OG00865.6
OG00952.4
OG01070.8
OG01152.6
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
Title
Measurements
OG00064.7
OG00120.0
OG00255.6
OG003
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
Title
Measurements
OG00058.8
OG00150.0
OG00261.1
OG003
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
Title
Measurements
OG00082.4
OG00150.0
OG00261.1
OG003
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
Title
Measurements
OG00082.4
OG00146.2
OG00261.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.52
Odds Ratio (OR)
0.64
2-Sided
95
0.16
2.56
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.48
Odds Ratio (OR)
0.67
2-Sided
95
0.23
1.99
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.93
Odds Ratio (OR)
0.95
2-Sided
95
0.32
2.81
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.013
Odds Ratio (OR)
6.12
2-Sided
95
1.47
25.60
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.031
Odds Ratio (OR)
5.49
2-Sided
95
1.17
25.77
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.059
Odds Ratio (OR)
3.84
2-Sided
95
0.95
15.58
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.36
Odds Ratio (OR)
1.91
2-Sided
95
0.48
7.58
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.26
Odds Ratio (OR)
0.34
2-Sided
95
0.05
2.17
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.33
Odds Ratio (OR)
0.43
2-Sided
95
0.08
2.31
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.94
Odds Ratio (OR)
1.07
2-Sided
95
0.17
6.68
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.29
Odds Ratio (OR)
0.44
2-Sided
95
0.09
2.02
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.15
Odds Ratio (OR)
0.28
2-Sided
95
0.05
1.60
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.11
Odds Ratio (OR)
0.29
2-Sided
95
0.06
1.34
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.26
Odds Ratio (OR)
0.41
2-Sided
95
0.09
1.89
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.28
Odds Ratio (OR)
2.67
2-Sided
95
0.44
16.17
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.36
Odds Ratio (OR)
2.39
2-Sided
95
0.37
15.46
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.56
Odds Ratio (OR)
1.68
2-Sided
95
0.29
9.72
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.84
Odds Ratio (OR)
0.83
2-Sided
95
0.15
4.76
Superiority or Other (legacy)
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00017
OG00113
OG00218
OG00315
OG00435
OG00515
OG00635
OG00733
OG00832
OG00924
OG01024
OG01120
Title
Denominators
Categories
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
Title
Measurements
OG00064.7
OG00130.8
OG00266.7
OG00373.3
OG00457.6
OG00557.1
OG00651.4
OG00766.7
OG00871.9
OG00966.7
OG01091.7
OG01168.4
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
Title
Measurements
OG00082.4
OG00140.0
OG00272.2
OG003
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
Title
Measurements
OG00076.5
OG00160.0
OG00277.8
OG003
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
Title
Measurements
OG00094.1
OG00170.0
OG00277.8
OG003
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
Title
Measurements
OG00094.1
OG00161.5
OG00277.8
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.48
Odds Ratio (OR)
0.61
2-Sided
95
0.16
2.38
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.58
Odds Ratio (OR)
0.74
2-Sided
95
0.25
2.17
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.93
Odds Ratio (OR)
1.05
2-Sided
95
0.34
3.28
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.023
Odds Ratio (OR)
12.16
2-Sided
95
1.40
105.30
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.042
Odds Ratio (OR)
9.48
2-Sided
95
1.08
83.24
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.047
Odds Ratio (OR)
9.03
2-Sided
95
1.03
79.19
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.23
Odds Ratio (OR)
2.79
2-Sided
95
0.52
14.90
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.058
Odds Ratio (OR)
0.10
2-Sided
95
0.01
1.08
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.15
Odds Ratio (OR)
0.18
2-Sided
95
0.02
1.87
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.55
Odds Ratio (OR)
0.46
2-Sided
95
0.04
5.99
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.11
Odds Ratio (OR)
0.16
2-Sided
95
0.02
1.48
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.054
Odds Ratio (OR)
0.10
2-Sided
95
0.01
1.05
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.059
Odds Ratio (OR)
0.12
2-Sided
95
0.01
1.08
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.12
Odds Ratio (OR)
0.17
2-Sided
95
0.02
1.58
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.64
Odds Ratio (OR)
2.00
2-Sided
95
0.11
35.46
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.76
Odds Ratio (OR)
1.56
2-Sided
95
0.09
27.42
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.79
Odds Ratio (OR)
1.49
2-Sided
95
0.08
26.47
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.55
Odds Ratio (OR)
0.46
2-Sided
95
0.04
5.77
Superiority or Other (legacy)
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00017
OG00113
OG00218
OG00315
OG00435
OG00515
OG00635
OG00733
OG00832
OG00924
OG01024
OG01120
Title
Denominators
Categories
Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18
Title
Measurements
OG000-0.80± 0.178
OG001-0.59± 0.184
OG002-0.83± 0.161
OG003-0.96± 0.171
OG004-0.66± 0.115
OG005-0.77± 0.191
OG006-0.52± 0.123
OG007-0.68± 0.115
OG008-0.68± 0.120
OG009-0.64± 0.145
OG010-1.12± 0.135
OG011-0.76± 0.156
Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18
Title
Measurements
OG000-0.83± 0.157
OG001-0.48± 0.185
OG002-0.93± 0.142
OG003
Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19
Title
Measurements
OG000-0.86± 0.173
OG001-0.65± 0.204
OG002-1.00± 0.157
OG003
Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19
Title
Measurements
OG000-0.84± 0.420
OG001-0.54± 0.493
OG002-0.87± 0.379
OG003
EOT; n=14,13,17,15,35,13,29,33,31,23,24,19
Title
Measurements
OG000-0.86± 0.411
OG001-0.80± 0.424
OG002-0.88± 0.372
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.
Stratified Rank ANCOVA
P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.
0.25
All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
LS Mean Difference
-0.27
Standard Error of the Mean
0.495
2-Sided
95
-1.24
0.71
Superiority or Other (legacy)
OG004
OG006
Stratified Rank ANCOVA
0.35
LS Mean Difference
0.05
Standard Error of the Mean
0.383
2-Sided
95
-0.70
0.81
Superiority or Other (legacy)
OG004
OG007
Stratified Rank ANCOVA
1.0
LS Mean Difference
-0.01
Standard Error of the Mean
0.371
2-Sided
95
-0.74
0.72
Superiority or Other (legacy)
OG004
OG008
Stratified Rank ANCOVA
0.003
LS Mean Difference
-0.34
Standard Error of the Mean
0.377
2-Sided
95
-1.08
0.41
Superiority or Other (legacy)
OG004
OG009
Stratified Rank ANCOVA
0.12
LS Mean Difference
-0.22
Standard Error of the Mean
0.413
2-Sided
95
-1.04
0.59
Superiority or Other (legacy)
OG004
OG010
Stratified Rank ANCOVA
0.24
LS Mean Difference
0.58
Standard Error of the Mean
0.405
2-Sided
95
-0.21
1.38
Superiority or Other (legacy)
OG004
OG011
Stratified Rank ANCOVA
0.54
LS Mean Difference
-0.08
Standard Error of the Mean
0.435
2-Sided
95
-0.94
0.78
Superiority or Other (legacy)
OG000
OG001
Stratified Rank ANCOVA
0.95
LS Mean Difference
0.06
Standard Error of the Mean
0.590
2-Sided
95
-1.10
1.22
Superiority or Other (legacy)
OG000
OG002
Stratified Rank ANCOVA
0.74
LS Mean Difference
-0.02
Standard Error of the Mean
0.552
2-Sided
95
-1.11
1.07
Superiority or Other (legacy)
OG000
OG003
Stratified Rank ANCOVA
0.89
LS Mean Difference
-0.31
Standard Error of the Mean
0.570
2-Sided
95
-1.43
0.82
Superiority or Other (legacy)
OG000
OG004
Stratified Rank ANCOVA
0.82
LS Mean Difference
-0.00
Standard Error of the Mean
0.487
2-Sided
95
-0.96
0.96
Superiority or Other (legacy)
OG000
OG005
Stratified Rank ANCOVA
0.58
LS Mean Difference
-0.27
Standard Error of the Mean
0.593
2-Sided
95
-1.44
0.90
Superiority or Other (legacy)
OG000
OG006
Stratified Rank ANCOVA
0.46
LS Mean Difference
0.05
Standard Error of the Mean
0.500
2-Sided
95
-0.93
1.04
Superiority or Other (legacy)
OG000
OG007
Stratified Rank ANCOVA
0.95
LS Mean Difference
-0.01
Standard Error of the Mean
0.490
2-Sided
95
-0.97
0.96
Superiority or Other (legacy)
OG000
OG008
Stratified Rank ANCOVA
0.18
LS Mean Difference
-0.34
Standard Error of the Mean
0.499
2-Sided
95
-1.32
0.65
Superiority or Other (legacy)
OG000
OG009
Stratified Rank ANCOVA
0.21
LS Mean Difference
-0.22
Standard Error of the Mean
0.517
2-Sided
95
-1.24
0.80
Superiority or Other (legacy)
OG000
OG010
Stratified Rank ANCOVA
0.72
LS Mean Difference
0.58
Standard Error of the Mean
0.516
2-Sided
95
-0.43
1.60
Superiority or Other (legacy)
OG000
OG011
Stratified Rank ANCOVA
0.92
LS Mean Difference
-0.08
Standard Error of the Mean
0.541
2-Sided
95
-1.15
0.98
Superiority or Other (legacy)
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.002
LS Mean Difference
-1.26
Standard Error of the Mean
0.412
2-Sided
95
-2.06
-0.45
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.16
LS Mean Difference
-0.48
Standard Error of the Mean
0.340
2-Sided
95
-1.15
0.19
Superiority or Other (legacy)
OG004
OG007
ANCOVA
<0.001
LS Mean Difference
-1.24
Standard Error of the Mean
0.340
2-Sided
95
-1.91
-0.57
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.001
LS Mean Difference
-1.13
Standard Error of the Mean
0.343
2-Sided
95
-1.80
-0.46
Superiority or Other (legacy)
OG004
OG009
ANCOVA
<0.001
LS Mean Difference
-1.37
Standard Error of the Mean
0.338
2-Sided
95
-2.03
-0.70
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.017
LS Mean Difference
-0.98
Standard Error of the Mean
0.409
2-Sided
95
-1.78
-0.18
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.004
LS Mean Difference
-1.18
Standard Error of the Mean
0.405
2-Sided
95
-1.98
-0.39
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.53
LS Mean Difference
0.29
Standard Error of the Mean
0.469
2-Sided
95
-0.63
1.22
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.85
LS Mean Difference
0.09
Standard Error of the Mean
0.468
2-Sided
95
-0.83
1.01
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.84
LS Mean Difference
-0.09
Standard Error of the Mean
0.468
2-Sided
95
-1.01
0.83
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.050
LS Mean Difference
0.80
Standard Error of the Mean
0.406
2-Sided
95
-0.00
1.59
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.33
LS Mean Difference
-0.46
Standard Error of the Mean
0.469
2-Sided
95
-1.38
0.46
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.44
LS Mean Difference
0.32
Standard Error of the Mean
0.407
2-Sided
95
-0.48
1.12
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.28
LS Mean Difference
-0.44
Standard Error of the Mean
0.408
2-Sided
95
-1.24
0.36
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.42
LS Mean Difference
-0.33
Standard Error of the Mean
0.410
2-Sided
95
-1.14
0.47
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.16
LS Mean Difference
-0.57
Standard Error of the Mean
0.406
2-Sided
95
-1.37
0.23
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.70
LS Mean Difference
-0.18
Standard Error of the Mean
0.467
2-Sided
95
-1.10
0.73
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.40
LS Mean Difference
-0.39
Standard Error of the Mean
0.464
2-Sided
95
-1.30
0.52
Superiority or Other (legacy)
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.062
LS Mean Difference
-0.15
Standard Error of the Mean
0.079
2-Sided
95
-0.30
0.01
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.15
LS Mean Difference
-0.09
Standard Error of the Mean
0.065
2-Sided
95
-0.22
0.03
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.007
LS Mean Difference
-0.18
Standard Error of the Mean
0.065
2-Sided
95
-0.30
-0.05
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.017
LS Mean Difference
-0.16
Standard Error of the Mean
0.066
2-Sided
95
-0.29
-0.03
Superiority or Other (legacy)
OG004
OG009
ANCOVA
<0.001
LS Mean Difference
-0.23
Standard Error of the Mean
0.065
2-Sided
95
-0.35
-0.10
Superiority or Other (legacy)
OG004
OG010
ANCOVA
<0.001
LS Mean Difference
-0.26
Standard Error of the Mean
0.078
2-Sided
95
-0.41
-0.11
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.070
LS Mean Difference
-0.14
Standard Error of the Mean
0.077
2-Sided
95
-0.29
0.01
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.15
LS Mean Difference
0.13
Standard Error of the Mean
0.090
2-Sided
95
-0.05
0.31
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.57
LS Mean Difference
0.05
Standard Error of the Mean
0.089
2-Sided
95
-0.12
0.23
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.89
LS Mean Difference
0.01
Standard Error of the Mean
0.089
2-Sided
95
-0.16
0.19
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.086
LS Mean Difference
0.13
Standard Error of the Mean
0.077
2-Sided
95
-0.02
0.29
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.88
LS Mean Difference
-0.01
Standard Error of the Mean
0.090
2-Sided
95
-0.19
0.16
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.61
LS Mean Difference
0.04
Standard Error of the Mean
0.078
2-Sided
95
-0.11
0.19
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.58
LS Mean Difference
-0.04
Standard Error of the Mean
0.078
2-Sided
95
-0.20
0.11
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.76
LS Mean Difference
-0.02
Standard Error of the Mean
0.078
2-Sided
95
-0.18
0.13
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.23
LS Mean Difference
-0.09
Standard Deviation
0.077
2-Sided
95
-0.25
0.06
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.15
LS Mean Difference
-0.13
Standard Error of the Mean
0.089
2-Sided
95
-0.30
0.05
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.94
LS Mean Difference
-0.01
Standard Error of the Mean
0.088
2-Sided
95
-0.18
0.17
Superiority or Other (legacy)
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30
Title
Measurements
OG000-0.81± 0.212
OG001-0.87± 0.212
OG002-0.88± 0.209
OG003-1.31± 0.219
OG004-0.92± 0.142
OG005-0.91± 0.255
OG006-0.86± 0.155
OG007-0.96± 0.164
OG008-0.89± 0.155
OG009-1.02± 0.155
OG010-1.13± 0.182
OG011-1.31± 0.223
Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30
Title
Measurements
OG000-0.76± 0.224
OG001-0.93± 0.228
OG002-0.70± 0.214
OG003
Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30
Title
Measurements
OG000-0.97± 0.226
OG001-0.90± 0.223
OG002-1.11± 0.213
OG003
Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31
Title
Measurements
OG000-0.92± 0.246
OG001-0.97± 0.242
OG002-0.93± 0.231
OG003
EOT; n=33,34,35,32,76,24,63,56,64,65,46,32
Title
Measurements
OG000-0.63± 0.244
OG001-1.04± 0.241
OG002-0.95± 0.237
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.29
LS Mean Difference
-0.35
Standard Error of the Mean
0.330
2-Sided
95
-0.99
0.30
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.15
LS Mean Difference
0.35
Standard Error of the Mean
0.239
2-Sided
95
-0.12
0.82
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.99
LS Mean Difference
0.00
Standard Error of the Mean
0.248
2-Sided
95
-0.48
0.49
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.76
LS Mean Difference
-0.07
Standard Error of the Mean
0.239
2-Sided
95
-0.54
0.40
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.30
LS Mean Difference
-0.25
Standard Error of the Mean
0.238
2-Sided
95
-0.71
0.22
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.43
LS Mean Difference
-0.21
Standard Error of the Mean
0.262
2-Sided
95
-0.72
0.31
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.40
LS Mean Difference
-0.25
Standard Error of the Mean
0.296
2-Sided
95
-0.83
0.33
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.24
LS Mean Difference
-0.40
Standard Error of the Mean
0.343
2-Sided
95
-1.08
0.27
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.36
LS Mean Difference
-0.31
Standard Error of the Mean
0.340
2-Sided
95
-0.98
0.36
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.020
LS Mean Difference
-0.81
Standard Error of the Mean
0.348
2-Sided
95
-1.49
-0.13
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.011
LS Mean Difference
-0.75
Standard Error of the Mean
0.293
2-Sided
95
-1.33
-0.18
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.004
LS Mean Difference
-1.10
Standard Error of the Mean
0.377
2-Sided
95
-1.84
-0.36
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.18
LS Mean Difference
-0.40
Standard Error of the Mean
0.301
2-Sided
95
-1.00
0.19
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.015
LS Mean Difference
-0.75
Standard Error of the Mean
0.308
2-Sided
95
-1.35
-0.14
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.006
LS Mean Difference
-0.82
Standard Error of the Mean
0.301
2-Sided
95
-1.41
-0.23
Superiority or Other (legacy)
OG000
OG009
ANCOVA
<0.001
LS Mean Difference
-1.00
Standard Error of the Mean
0.300
2-Sided
95
-1.59
-0.41
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.003
LS Mean Difference
-0.96
Standard Error of the Mean
0.320
2-Sided
95
-1.59
-0.33
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.004
LS Mean Difference
-1.00
Standard Error of the Mean
0.348
2-Sided
95
-1.68
-0.31
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.15
LS Mean Difference
-0.25
Standard Error of the Mean
0.177
2-Sided
95
-0.60
0.09
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.78
LS Mean Difference
-0.04
Standard Error of the Mean
0.146
2-Sided
95
-0.33
0.25
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.58
LS Mean Difference
-0.08
Standard Error of the Mean
0.146
2-Sided
95
-0.37
0.21
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.60
LS Mean Difference
-0.08
Standard Error of the Mean
0.147
2-Sided
95
-0.37
0.21
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.017
LS Mean Difference
-0.35
Standard Error of the Mean
0.145
2-Sided
95
-0.63
-0.06
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.16
LS Mean Difference
-0.25
Standard Error of the Mean
0.176
2-Sided
95
-0.60
0.10
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.13
LS Mean Difference
-0.27
Standard Error of the Mean
0.175
2-Sided
95
-0.61
0.08
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.81
LS Mean Difference
0.05
Standard Error of the Mean
0.201
2-Sided
95
-0.35
0.44
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.67
LS Mean Difference
-0.08
Standard Error of the Mean
0.199
2-Sided
95
-0.48
0.31
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.77
LS Mean Difference
0.06
Standard Error of the Mean
0.200
2-Sided
95
-0.33
0.45
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.81
LS Mean Difference
0.04
Standard Error of the Mean
0.81
2-Sided
95
-0.30
0.38
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.30
LS Mean Difference
-0.21
Standard Error of the Mean
0.201
2-Sided
95
-0.60
0.18
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.99
LS Mean Difference
0.00
Standard Error of the Mean
0.174
2-Sided
95
-0.34
0.34
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.82
LS Mean Difference
-0.04
Standard Error of the Mean
0.175
2-Sided
95
-0.38
0.30
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.84
LS Mean Difference
-0.04
Standard Error of the Mean
0.175
2-Sided
95
-0.38
0.31
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.080
LS Mean Difference
-0.30
Standard Error of the Mean
0.173
2-Sided
95
-0.64
0.04
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.30
LS Mean Difference
-0.21
Standard Error of the Mean
0.200
2-Sided
95
-0.60
0.18
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.26
LS Mean Difference
-0.22
Standard Error of the Mean
0.199
2-Sided
95
-0.62
0.17
Superiority or Other (legacy)
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00078
OG00173
OG00276
OG00375
OG004147
OG00573
OG006141
OG007143
OG008136
OG009144
OG01076
OG01178
Title
Denominators
Categories
Title
Measurements
OG000-1.4± 0.14
OG001-1.4± 0.14
OG002-1.5± 0.14
OG003-1.5± 0.14
OG004-1.3± 0.10
OG005-1.5± 0.14
OG006-1.4± 0.10
OG007-1.7± 0.10
OG008-1.7± 0.10
OG009-1.8± 0.10
OG010-1.8± 0.14
OG011-1.6± 0.14
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.38
LS Mean Difference
-0.1
Standard Error of the Mean
0.17
2-Sided
95
-0.5
0.2
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.85
LS Mean Difference
-0.0
Standard Error of the Mean
0.14
2-Sided
95
-0.3
0.3
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.024
LS Mean Difference
-0.3
Standard Error of the Mean
0.14
2-Sided
95
-0.6
-0.0
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.005
LS Mean Difference
-0.4
Standard Error of the Mean
0.14
2-Sided
95
-0.7
-0.1
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.003
LS Mean Difference
-0.4
Standard Error of the Mean
0.14
2-Sided
95
-0.7
-0.1
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.004
LS Mean Difference
-0.5
Standard Error of the Mean
0.17
2-Sided
95
-0.8
-0.2
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.15
LS Mean Difference
-0.2
Standard Error of the Mean
0.17
2-Sided
95
-0.6
0.1
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.99
LS Mean Difference
0.0
Standard Error of the Mean
0.20
2-Sided
95
-0.4
0.4
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.67
LS Mean Difference
-0.1
Standard Error of the Mean
0.19
2-Sided
95
-0.5
0.3
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.44
LS Mean Difference
-0.1
Standard Error of the Mean
0.19
2-Sided
95
-0.5
0.2
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.88
LS Mean Difference
0.0
Standard Error of the Mean
0.17
2-Sided
95
-0.3
0.4
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.53
LS Mean Difference
-0.1
Standard Error of the Mean
0.20
2-Sided
95
-0.5
0.3
Superiority or Other (legacy)
OG000
OG006
ANCOVA
1.0
LS Mean Difference
-0.0
Standard Error of the Mean
0.17
2-Sided
95
-0.3
0.3
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.084
LS Mean Difference
-0.3
Standard Error of the Mean
0.17
2-Sided
95
-0.6
0.0
Superiority or Other (legacy)
OG008
ANCOVA
0.030
LS Mean Difference
-0.4
Standard Error of the Mean
0.17
2-Sided
95
-0.7
-0.0
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.020
LS Mean Difference
-0.4
Standard Error of the Mean
0.17
2-Sided
95
-0.7
-0.1
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.017
LS Mean Difference
-0.5
Standard Error of the Mean
0.19
2-Sided
95
-0.8
-0.1
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.26
LS Mean Difference
-0.2
Standard Error of the Mean
0.19
2-Sided
95
-0.6
0.2
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00078
OG00173
OG00276
OG00375
OG004147
OG00573
OG006141
OG007143
OG008136
OG009144
OG01076
OG01178
Title
Denominators
Categories
Title
Measurements
OG00069.2
OG00176.7
OG00278.9
OG00368.0
OG00472.8
OG00584.9
OG00674.5
OG00783.2
OG00877.9
OG00982.6
OG01082.9
OG01175.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.040
Odds Ratio (OR)
2.26
2-Sided
95
1.04
4.95
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.73
Odds Ratio (OR)
1.10
2-Sided
95
0.63
1.92
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.050
Odds Ratio (OR)
1.82
2-Sided
95
1.00
3.30
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.21
Odds Ratio (OR)
1.45
2-Sided
95
0.81
2.59
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.021
Odds Ratio (OR)
2.02
2-Sided
95
1.11
3.66
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.19
Odds Ratio (OR)
1.64
2-Sided
95
0.79
3.40
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.74
Odds Ratio (OR)
1.12
2-Sided
95
0.57
2.19
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.57
Odds Ratio (OR)
1.25
2-Sided
95
0.58
2.71
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.19
Odds Ratio (OR)
1.67
2-Sided
95
0.77
3.64
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.69
Odds Ratio (OR)
0.86
2-Sided
95
0.41
1.79
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.90
Odds Ratio (OR)
1.04
2-Sided
95
0.55
1.99
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.048
Odds Ratio (OR)
2.36
2-Sided
95
1.01
5.55
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.67
Odds Ratio (OR)
1.15
2-Sided
95
0.60
2.22
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.070
Odds Ratio (OR)
1.90
2-Sided
95
0.95
3.78
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.23
Odds Ratio (OR)
1.51
2-Sided
95
0.77
2.98
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.034
Odds Ratio (OR)
2.11
2-Sided
95
1.06
4.19
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.20
Odds Ratio (OR)
1.71
2-Sided
95
0.76
3.84
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.68
Odds Ratio (OR)
1.17
2-Sided
95
0.55
2.49
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00078
OG00173
OG00276
OG00375
OG004147
OG00573
OG006141
OG007143
OG008136
OG009144
OG01076
OG01178
Title
Denominators
Categories
Title
Measurements
OG00039.7
OG00142.5
OG00238.2
OG00344.0
OG00442.2
OG00546.6
OG00648.2
OG00752.4
OG00854.4
OG00954.9
OG01057.9
OG01150.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Regression, Logistic
0.62
Odds Ratio (OR)
1.16
2-Sided
95
0.64
2.12
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.25
Odds Ratio (OR)
1.33
2-Sided
95
0.82
2.17
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.11
Odds Ratio (OR)
1.48
2-Sided
95
0.91
2.41
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.020
Odds Ratio (OR)
1.81
2-Sided
95
1.10
2.97
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.012
Odds Ratio (OR)
1.87
2-Sided
95
1.15
3.05
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.072
Odds Ratio (OR)
1.72
2-Sided
95
0.95
3.10
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.29
Odds Ratio (OR)
1.37
2-Sided
95
0.77
2.44
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.94
Odds Ratio (OR)
0.98
2-Sided
95
0.49
1.93
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.80
Odds Ratio (OR)
0.91
2-Sided
95
0.46
1.81
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.67
Odds Ratio (OR)
1.16
2-Sided
95
0.59
2.28
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
1.0
Odds Ratio (OR)
1.00
2-Sided
95
0.55
1.80
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.66
Odds Ratio (OR)
1.16
2-Sided
95
0.59
2.31
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.35
Odds Ratio (OR)
1.33
2-Sided
95
0.73
2.40
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.19
Odds Ratio (OR)
1.48
2-Sided
95
0.82
2.67
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.054
Odds Ratio (OR)
1.80
2-Sided
95
0.99
3.28
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.038
Odds Ratio (OR)
1.87
2-Sided
95
1.04
3.38
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.12
Odds Ratio (OR)
1.72
2-Sided
95
0.87
3.39
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.36
Odds Ratio (OR)
1.37
2-Sided
95
0.70
2.67
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00078
OG00173
OG00276
OG00375
OG004147
OG00573
OG006141
OG007143
OG008136
OG009144
OG01076
OG01178
Title
Denominators
Categories
Title
Measurements
OG0006.4
OG0014.1
OG0025.3
OG0034.0
OG0044.8
OG0052.7
OG0064.3
OG0072.8
OG0082.9
OG0091.4
OG0101.3
OG0116.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.32
Odds Ratio (OR)
0.40
2-Sided
95
0.06
2.43
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.65
Odds Ratio (OR)
0.75
2-Sided
95
0.21
2.61
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.39
Odds Ratio (OR)
0.54
2-Sided
95
0.13
2.19
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.22
Odds Ratio (OR)
0.41
2-Sided
95
0.10
1.67
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.082
Odds Ratio (OR)
0.22
2-Sided
95
0.04
1.22
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.36
Odds Ratio (OR)
0.36
2-Sided
95
0.04
3.20
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.51
Odds Ratio (OR)
1.55
2-Sided
95
0.42
5.71
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.99
Odds Ratio (OR)
1.01
2-Sided
95
0.19
5.36
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.96
Odds Ratio (OR)
1.04
2-Sided
95
0.24
4.59
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.57
Odds Ratio (OR)
0.62
2-Sided
95
0.12
3.30
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.93
Odds Ratio (OR)
1.06
2-Sided
95
0.28
3.95
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.37
Odds Ratio (OR)
0.42
2-Sided
95
0.06
2.79
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.74
Odds Ratio (OR)
0.79
2-Sided
95
0.20
3.13
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.46
Odds Ratio (OR)
0.57
2-Sided
95
0.12
2.59
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.28
Odds Ratio (OR)
0.44
2-Sided
95
0.10
1.96
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.11
Odds Ratio (OR)
0.23
2-Sided
95
0.04
1.40
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.40
Odds Ratio (OR)
0.38
2-Sided
95
0.04
3.66
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.50
Odds Ratio (OR)
1.64
2-Sided
95
0.39
6.85
Superiority or Other (legacy)
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00079
OG00175
OG00276
OG00377
OG004150
OG00575
OG006144
OG007145
OG008139
OG009146
OG01078
OG01178
Title
Denominators
Categories
Title
Measurements
OG000-25.5± 1.96
OG001-27.1± 2.01
OG002-27.5± 2.00
OG003-29.8± 1.99
OG004-26.8± 1.42
OG005-29.9± 2.01
OG006-28.0± 1.45
OG007-31.7± 1.45
OG008-32.0± 1.48
OG009-33.5± 1.44
OG010-33.6± 1.97
OG011-31.4± 1.97
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.21
LS Mean Difference
-3.1
Standard Error of the Mean
2.47
2-Sided
95
-8.0
1.7
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.54
LS Mean Difference
-1.3
Standard Error of the Mean
2.03
2-Sided
95
-5.2
2.7
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.016
LS Mean Difference
-4.9
Standard Error of the Mean
2.03
2-Sided
95
-8.9
-0.9
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.011
LS Mean Difference
-5.2
Standard Error of the Mean
2.05
2-Sided
95
-9.3
-1.2
Superiority or Other (legacy)
OG004
OG009
ANCOVA
<0.001
LS Mean Difference
-6.7
Standard Error of the Mean
2.03
2-Sided
95
-10.7
-2.8
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.005
LS Mean Difference
-6.8
Standard Error of the Mean
2.43
2-Sided
95
-11.6
-2.0
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.056
LS Mean Difference
-4.7
Standard Error of the Mean
2.44
2-Sided
95
-9.4
0.1
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.56
LS Mean Difference
-1.6
Standard Error of the Mean
2.81
2-Sided
95
-7.1
3.9
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.48
LS Mean Difference
-2.0
Standard Error of the Mean
2.80
2-Sided
95
-7.5
3.5
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.13
LS Mean Difference
-4.3
Standard Error of the Mean
0.13
2-Sided
95
-9.8
1.2
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.61
LS Mean Difference
-1.2
Standard Error of the Mean
2.42
2-Sided
95
-6.0
3.5
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.12
LS Mean Difference
-4.4
Standard Error of the Mean
2.81
2-Sided
95
-9.9
1.2
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.31
LS Mean Difference
-2.5
Standard Error of the Mean
2.44
2-Sided
95
-7.3
2.3
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.012
LS Mean Difference
-6.1
Standard Error of the Mean
2.44
2-Sided
95
-10.9
-1.3
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.008
LS Mean Difference
-6.5
Standard Error of the Mean
2.46
2-Sided
95
-11.3
-1.7
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.001
LS Mean Difference
-8.0
Standard Error of the Mean
2.44
2-Sided
95
-12.8
-3.2
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.004
LS Mean Difference
-8.0
Standard Error of the Mean
2.78
2-Sided
95
-13.5
-2.6
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.035
LS Mean Difference
-5.9
Standard Error of the Mean
2.79
2-Sided
95
-11.4
-0.4
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00079
OG00175
OG00276
OG00377
OG004150
OG00575
OG006144
OG007145
OG008139
OG009146
OG01078
OG01178
Title
Denominators
Categories
Title
Measurements
OG00073.4
OG00184.0
OG00278.9
OG00385.7
OG00481.3
OG00585.3
OG00682.6
OG00785.5
OG00885.6
OG00988.4
OG01088.5
OG01183.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.40
Odds Ratio (OR)
1.42
2-Sided
95
0.63
3.20
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.89
Odds Ratio (OR)
1.04
2-Sided
95
0.55
1.97
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.57
Odds Ratio (OR)
1.21
2-Sided
95
0.63
2.33
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.36
Odds Ratio (OR)
1.36
2-Sided
95
0.70
2.66
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.15
Odds Ratio (OR)
1.66
2-Sided
95
0.83
3.32
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.31
Odds Ratio (OR)
1.55
2-Sided
95
0.67
3.59
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.81
Odds Ratio (OR)
0.91
2-Sided
95
0.42
1.95
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.19
Odds Ratio (OR)
1.75
2-Sided
95
0.75
4.08
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.59
Odds Ratio (OR)
1.25
2-Sided
95
0.56
2.77
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.13
Odds Ratio (OR)
1.97
2-Sided
95
0.83
4.71
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.20
Odds Ratio (OR)
1.57
2-Sided
95
0.78
3.16
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.070
Odds Ratio (OR)
2.24
2-Sided
95
0.94
5.34
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.17
Odds Ratio (OR)
1.64
2-Sided
95
0.81
3.33
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.084
Odds Ratio (OR)
1.90
2-Sided
95
0.92
3.92
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.043
Odds Ratio (OR)
2.14
2-Sided
95
1.02
4.48
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.013
Odds Ratio (OR)
2.61
2-Sided
95
1.22
5.58
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.053
Odds Ratio (OR)
2.43
2-Sided
95
0.99
5.97
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.39
Odds Ratio (OR)
1.43
2-Sided
95
0.63
3.26
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00079
OG00175
OG00276
OG00377
OG004150
OG00575
OG006144
OG007145
OG008139
OG009146
OG01078
OG01178
Title
Denominators
Categories
Title
Measurements
OG00024.5± 2.03
OG00122.5± 2.08
OG00225.8± 2.07
OG00327.7± 2.05
OG00423.7± 1.47
OG00526.6± 2.08
OG00625.5± 1.50
OG00728.5± 1.50
OG00829.2± 1.53
OG00930.1± 1.49
OG01030.3± 2.04
OG01128.9± 2.04
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.
ANCOVA
0.26
LS Mean Difference
2.9
Standard Error of the Mean
2.55
2-Sided
95
-2.1
7.9
Superiority or Other (legacy)
OG004
OG006
ANCOVA
0.38
LS Mean Difference
1.8
Standard Error of the Mean
2.10
2-Sided
95
-2.3
6.0
Superiority or Other (legacy)
OG004
OG007
ANCOVA
0.022
LS Mean Differrence
4.8
Standard Error of the Mean
2.10
2-Sided
95
0.7
8.9
Superiority or Other (legacy)
OG004
OG008
ANCOVA
0.010
LS Mean Difference
5.5
Standard Error of the Mean
2.12
2-Sided
95
1.3
9.7
Superiority or Other (legacy)
OG004
OG009
ANCOVA
0.002
LS Mean Difference
6.4
Standard Error of the Mean
2.09
2-Sided
95
2.3
10.5
Superiority or Other (legacy)
OG004
OG010
ANCOVA
0.008
LS Mean Difference
6.7
Standard Error of the Mean
2.52
2-Sided
95
1.7
11.6
Superiority or Other (legacy)
OG004
OG011
ANCOVA
0.037
LS Mean Difference
5.3
Standard Error of the Mean
2.52
2-Sided
95
0.3
10.2
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.50
LS Mean Difference
-2.0
Standard Error of the Mean
2.90
2-Sided
95
-7.7
3.7
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.65
LS Mean Difference
1.3
Standard Error of the Mean
2.89
2-Sided
95
-4.4
7.0
Superiority or Other (legacy)
OG000
OG003
ANCOVA
0.25
LS Mean Difference
3.3
Standard Error of the Mean
2.88
2-Sided
95
-2.4
8.9
Superiority or Other (legacy)
OG000
OG004
ANCOVA
0.76
LS Mean Difference
-0.8
Standard Error of the Mean
2.51
2-Sided
95
-5.7
4.1
Superiority or Other (legacy)
OG000
OG005
ANCOVA
0.47
LS Mean Difference
2.1
Standard Error of the Mean
2.91
2-Sided
95
-3.6
7.8
Superiority or Other (legacy)
OG000
OG006
ANCOVA
0.67
LS Mean Difference
1.1
Standard Error of the Mean
2.52
2-Sided
95
-3.9
6.0
Superiority or Other (legacy)
OG000
OG007
ANCOVA
0.11
LS Mean Difference
4.0
Standard Error of the Mean
2.52
2-Sided
95
-0.9
9.0
Superiority or Other (legacy)
OG000
OG008
ANCOVA
0.062
LS Mean Difference
4.7
Standard Error of the Mean
2.54
2-Sided
95
-0.2
9.7
Superiority or Other (legacy)
OG000
OG009
ANCOVA
0.025
LS Mean Difference
5.6
Standard Error of the Mean
2.52
2-Sided
95
0.7
10.6
Superiority or Other (legacy)
OG000
OG010
ANCOVA
0.041
LS Mean Difference
5.9
Standard Error of the Mean
2.88
2-Sided
95
0.2
11.5
Superiority or Other (legacy)
OG000
OG011
ANCOVA
0.12
LS Mean Difference
4.5
Standard Error of the Mean
2.88
2-Sided
95
-1.2
10.1
Superiority or Other (legacy)
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00079
OG00175
OG00276
OG00377
OG004150
OG00575
OG006144
OG007145
OG008139
OG009146
OG01078
OG01178
Title
Denominators
Categories
Title
Measurements
OG00067.1
OG00157.3
OG00271.1
OG00374.0
OG00472.7
OG00574.7
OG00672.9
OG00778.6
OG00877.0
OG00984.2
OG01079.5
OG01182.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
Regression, Logistic
0.92
Odds Ratio (OR)
1.04
2-Sided
95
0.52
2.08
Superiority or Other (legacy)
OG004
OG006
Regression, Logistic
0.98
Odds Ratio (OR)
1.01
2-Sided
95
0.58
1.77
Superiority or Other (legacy)
OG004
OG007
Regression, Logistic
0.45
Odds Ratio (OR)
1.25
2-Sided
95
0.70
2.23
Superiority or Other (legacy)
OG004
OG008
Regression, Logistic
0.24
Odds Ratio (OR)
1.41
2-Sided
95
0.79
2.53
Superiority or Other (legacy)
OG004
OG009
Regression, Logistic
0.012
Odds Ratio (OR)
2.21
2-Sided
95
1.19
4.09
Superiority or Other (legacy)
OG004
OG010
Regression, Logistic
0.32
Odds Ratio (OR)
1.43
2-Sided
95
0.70
2.90
Superiority or Other (legacy)
OG004
OG011
Regression, Logistic
0.27
Odds Ratio (OR)
1.51
2-Sided
95
0.72
3.14
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
0.064
Odds Ratio (OR)
0.50
2-Sided
95
0.24
1.04
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
0.57
Odds Ratio (OR)
1.24
2-Sided
95
0.59
2.61
Superiority or Other (legacy)
OG000
OG003
Regression, Logistic
0.55
Odds Ratio (OR)
1.26
2-Sided
95
0.59
2.68
Superiority or Other (legacy)
OG000
OG004
Regression, Logistic
0.75
Odds Ratio (OR)
1.11
2-Sided
95
0.58
2.13
Superiority or Other (legacy)
OG000
OG005
Regression, Logistic
0.72
Odds Ratio (OR)
1.15
2-Sided
95
0.53
2.49
Superiority or Other (legacy)
OG000
OG006
Regression, Logistic
0.74
Odds Ratio (OR)
1.12
2-Sided
95
0.58
2.15
Superiority or Other (legacy)
OG000
OG007
Regression, Logistic
0.34
Odds Ratio (OR)
1.39
2-Sided
95
0.71
2.71
Superiority or Other (legacy)
OG000
OG008
Regression, Logistic
0.19
Odds Ratio (OR)
1.57
2-Sided
95
0.80
3.07
Superiority or Other (legacy)
OG000
OG009
Regression, Logistic
0.012
Odds Ratio (OR)
2.45
2-Sided
95
1.22
4.94
Superiority or Other (legacy)
OG000
OG010
Regression, Logistic
0.25
Odds Ratio (OR)
1.59
2-Sided
95
0.72
3.47
Superiority or Other (legacy)
OG000
OG011
Regression, Logistic
0.21
Odds Ratio (OR)
1.67
2-Sided
95
0.74
3.75
Superiority or Other (legacy)
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
No problem → No problem
Title
Measurements
OG00060
OG00158
OG00263
OG00359
OG004118
OG00554
OG00694
OG007113
OG008102
OG009120
OG01059
OG01156
No problem → Some problems
Title
Measurements
OG0006
OG0011
OG0024
OG003
No problem → Confined to bed
Title
Measurements
OG0000
OG0010
OG0020
OG003
No problem → Missing data
Title
Measurements
OG0001
OG0011
OG0021
OG003
Some problems → No problems
Title
Measurements
OG0005
OG0016
OG0026
OG003
Some problems → Some problems
Title
Measurements
OG0008
OG00110
OG0023
OG003
Some problems → Confined to bed
Title
Measurements
OG0000
OG0010
OG0020
OG003
Some problems → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Confined → No problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Confined → Some problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Confined → Confined to bed
Title
Measurements
OG0000
OG0010
OG0020
OG003
Confined → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → No problem
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Some problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Confined to bed
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
No problem → No problem
Title
Measurements
OG00076
OG00169
OG00273
OG00372
OG004138
OG00568
OG006128
OG007138
OG008130
OG009141
OG01074
OG01172
No problem → Some problems
Title
Measurements
OG0000
OG0011
OG0023
OG003
No problem → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
No problem → Missing data
Title
Measurements
OG0001
OG0010
OG0021
OG003
Some problems → No problems
Title
Measurements
OG0001
OG0014
OG0020
OG003
Some problems → Some problems
Title
Measurements
OG0002
OG0011
OG0020
OG003
Some problems → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Some problems → Missing data
Title
Measurements
OG0000
OG0011
OG0020
OG003
Unable → No problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unable → Some problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unable → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unable → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → No problem
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Some problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
No problem → No problem
Title
Measurements
OG00062
OG00152
OG00258
OG00360
OG004115
OG00557
OG00689
OG007110
OG008106
OG009109
OG01057
OG01148
No problem → Some problems
Title
Measurements
OG0002
OG0012
OG0023
OG003
No problem → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
No problem → Missing data
Title
Measurements
OG0000
OG0010
OG0021
OG003
Some problems → No problems
Title
Measurements
OG00011
OG00111
OG0028
OG003
Some problems → Some problems
Title
Measurements
OG0004
OG00110
OG0026
OG003
Some problems → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Some problems → Missing data
Title
Measurements
OG0001
OG0011
OG0020
OG003
Unable → No problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unable → Some problems
Title
Measurements
OG0000
OG0010
OG0021
OG003
Unable → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unable → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → No problem
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Some problems
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Unable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
No pain → No pain
Title
Measurements
OG00038
OG00133
OG00240
OG00338
OG00470
OG00535
OG00667
OG00761
OG00866
OG00973
OG01039
OG01132
No pain → Moderate pain
Title
Measurements
OG0009
OG00112
OG0026
OG003
No pain → Extreme pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
No pain → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Moderate pain → No pain
Title
Measurements
OG00012
OG00114
OG00210
OG003
Moderate pain → Moderate pain
Title
Measurements
OG00016
OG00115
OG00219
OG003
Moderate pain → Extreme pain
Title
Measurements
OG0001
OG0011
OG0020
OG003
Moderate pain → Missing data
Title
Measurements
OG0001
OG0010
OG0020
OG003
Extreme pain → No pain
Title
Measurements
OG0001
OG0010
OG0020
OG003
Extreme pain → Moderate pain
Title
Measurements
OG0002
OG0010
OG0020
OG003
Extreme pain → Extreme pain
Title
Measurements
OG0000
OG0010
OG0021
OG003
Extreme pain → Missing data
Title
Measurements
OG0000
OG0011
OG0021
OG003
Missing data → No pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Moderate pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Extreme pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
No anxiety → No anxiety
Title
Measurements
OG00041
OG00138
OG00239
OG00342
OG00476
OG00536
OG00681
OG00778
OG00876
OG00980
OG01044
OG01136
No anxiety → Moderate anxiety
Title
Measurements
OG0005
OG0018
OG0027
OG003
No anxiety → Extreme anxiety
Title
Measurements
OG0001
OG0010
OG0020
OG003
No anxiety → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Moderate anxiety → No anxiety
Title
Measurements
OG00017
OG0019
OG00215
OG003
Moderate anxiety → Moderate anxiety
Title
Measurements
OG00013
OG00118
OG00214
OG003
Moderate anxiety → Extreme anxiety
Title
Measurements
OG0000
OG0010
OG0021
OG003
Moderate anxiety → Missing data
Title
Measurements
OG0000
OG0011
OG0021
OG003
Extreme anxiety → No anxiety
Title
Measurements
OG0000
OG0010
OG0020
OG003
Extreme anxiety → Moderate anxiety
Title
Measurements
OG0002
OG0011
OG0020
OG003
Extreme anxiety → Extreme anxiety
Title
Measurements
OG0000
OG0011
OG0020
OG003
Extreme anxiety → Missing data
Title
Measurements
OG0001
OG0010
OG0020
OG003
Missing data → No anxiety
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Moderate anxiety
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Extreme anxiety
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing data → Missing data
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00079
OG00175
OG00276
OG00377
OG004150
OG00575
OG006144
OG007145
OG008139
OG009146
OG01078
OG01178
Title
Denominators
Categories
Title
Measurements
OG00013.1± 21.11
OG0015.8± 19.38
OG00214.3± 22.38
OG00311.1± 19.26
OG00411.9± 21.33
OG00513.3± 21.81
OG00611.6± 21.94
OG00712.5± 19.95
OG00811.8± 18.91
OG00915.9± 20.94
OG01015.3± 24.17
OG01111.1± 23.18
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
OG003
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00080
OG00176
OG00277
OG00377
OG004150
OG00576
OG006146
OG007147
OG008141
OG009150
OG01078
OG01180
Title
Denominators
Categories
Percent work time missed
Title
Measurements
OG000-2.44± 10.580
OG0010.53± 3.031
OG002-0.24± 1.988
OG003-2.85± 11.205
OG004-1.29± 12.606
OG005-0.28± 2.737
OG006-0.55± 12.816
OG007-0.83± 17.199
OG008-0.84± 5.330
OG009-1.65± 4.654
OG0100.79± 6.757
OG011-1.12± 11.025
Percent impairment while working
Title
Measurements
OG000-7.50± 24.539
OG001-16.13± 24.314
OG002-10.00± 22.220
OG003
Percent overall work impairment
Title
Measurements
OG000-9.50± 24.090
OG001-16.32± 24.653
OG002-9.91± 21.464
OG003
Percent activity impairment
Title
Measurements
OG000-9.62± 26.989
OG001-14.52± 27.439
OG002-13.95± 26.386
OG003
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
OG004
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
OG005
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
OG006
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG007
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG008
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG009
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
OG010
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
OG011
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
Units
Counts
Participants
OG00078
OG00173
OG00276
OG00375
OG004147
OG00573
OG006141
OG007143
OG008136
OG009144
OG01076
OG01178
Title
Denominators
Categories
Title
Measurements
OG0002.44± 0.298
OG0012.61± 0.307
OG0023.17± 0.301
OG0033.10± 0.303
OG0042.78± 0.217
OG0052.96± 0.307
OG0062.96± 0.221
OG0073.24± 0.220
OG0083.47± 0.225
OG0093.24± 0.219
OG0103.51± 0.301
OG0113.72± 0.297
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.
The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.
LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.