Urinary Bladder Diseases, Urinary Bladder, Overactive, Urologic Diseases
Conditions
Keywords
Vesitrim, Frequency, Urgency, Urgency incontinence, Urinary incontinence, Overactive Bladder (OAB), Micturition, Mirabegron, YM178, Vesicare, Solifenacin
Brief summary
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
Interventions
oral tablet
oral tablet
Sponsors
Study design
Eligibility
Inclusion criteria
* Subject is willing and able to complete the micturition diary and questionnaires correctly * Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months * Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit
Exclusion criteria
* Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control * Subject has neurogenic bladder * 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 a cough provocation test) * Subject has an indwelling catheter or practices intermittent self-catheterization * Subject has diabetic neuropathy * Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated * The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening * Subject receives 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 has moderate to severe hepatic impairment * Subject has severe renal impairment or end stage renal disease * Subject has severe uncontrolled hypertension * Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval * Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients * Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening * Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives * Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria * Subject's last antimuscarinic treatment was solifenacin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Baseline and final visit (up to Week 12) | A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | — |
| Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Baseline and Week 4, Week 8, Week 12 | Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. |
| Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Baseline and Week 4, Week 8 , Week 12 | The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. |
| Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Baseline and Week 4, Week 8, Week 12 | A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. |
| Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0. |
| Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit. |
| Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit. |
| Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Baseline and Week 4 | The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 8 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 8 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 8 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 8 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 8 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 12 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 12 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 12 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 12 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 12 | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and final visit (up to Week 12) | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and final visit (up to Week 12) | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and final visit (up to Week 12) | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and final visit (up to Week 12) | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and final visit (up to Week 12) | The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]). |
| Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Baseline and Week 4, Week 8, Week 12 | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. |
| Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Baseline and Week 4, Week 8, Week 12 | The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Baseline and Week 4, Week 8, Week 12 | The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. |
| Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) | Baseline and Week 12 | The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely). |
| Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale | Baseline and Week 12 | The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied). |
| Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit | Baseline to Week 12 | A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline. |
| Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). |
| Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | Baseline to Week 12 | A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale. |
| Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | Baseline to final visit (up to Week 12) | A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale. |
| Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit | Baseline to Week 12 | A responder is defined as a participant with ≥1 point improvement in PPBC from baseline. |
| Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit | Baseline to Week 12 | A responder is defined as a participant with ≥2 point improvement in PPBC from baseline. |
| Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit | Baseline to Week 12 | A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline. |
Countries
Armenia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Participant flow
Recruitment details
Participants recruited for this study were men and women with overactive bladder (OAB) who had received 1 or more antimuscarinics in the past and who were dissatisfied with their last antimuscarinic treatment due to lack of efficacy (provided that their previous antimuscarinic was not solifenacin).
Pre-assignment details
Participants entered a 2-week, single-blind, placebo run-in period and completed a daily diary (including 3 consecutive days prior to the randomization visit for micturition and incontinence). After this, participants' eligibility criteria were re-confirmed and they were then randomized into the double-blind treatment period of the study.
Participants by arm
| Arm | Count |
|---|---|
| Mirabegron 50 mg Participants who received mirabegron 50 mg once daily for 12 weeks. | 936 |
| Solifenacin 5 mg Participants who received solifenacin 5 mg once daily for 12 weeks. | 934 |
| Total | 1,870 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 16 |
| Overall Study | Lack of Efficacy | 5 | 6 |
| Overall Study | Miscellaneous | 2 | 2 |
| Overall Study | Protocol Violation | 11 | 13 |
| Overall Study | Randomized but Never Received Drug | 7 | 10 |
| Overall Study | Withdrawal by Subject | 21 | 24 |
Baseline characteristics
| Characteristic | Solifenacin 5 mg | Total | Mirabegron 50 mg |
|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 13.6 | 57.0 years STANDARD_DEVIATION 13.93 | 56.7 years STANDARD_DEVIATION 14.25 |
| Mean Incontinence Episodes / 24 hours | 2.1 incontinence episodes STANDARD_DEVIATION 2.05 | 2.1 incontinence episodes STANDARD_DEVIATION 2.17 | 2.1 incontinence episodes STANDARD_DEVIATION 2.3 |
| Mean Level of Urgency | 2.6 units on a scale STANDARD_DEVIATION 0.49 | 2.6 units on a scale STANDARD_DEVIATION 0.49 | 2.6 units on a scale STANDARD_DEVIATION 0.49 |
| Mean Micturitions / 24 hours | 11.4 micturitions STANDARD_DEVIATION 2.89 | 11.5 micturitions STANDARD_DEVIATION 3.08 | 11.6 micturitions STANDARD_DEVIATION 3.25 |
| Mean Nocturia Episodes / 24 hours | 2.3 nocturia episodes STANDARD_DEVIATION 1.42 | 2.3 nocturia episodes STANDARD_DEVIATION 1.41 | 2.3 nocturia episodes STANDARD_DEVIATION 1.41 |
| Mean Number of Pads Used / 24 hours | 3.3 pads STANDARD_DEVIATION 3.7 | 3.2 pads STANDARD_DEVIATION 3.57 | 3.1 pads STANDARD_DEVIATION 3.43 |
| Mean Urgency Episodes (grade 3 or 4) / 24 hours | 7.8 urgency episodes STANDARD_DEVIATION 4.46 | 7.8 urgency episodes STANDARD_DEVIATION 4.61 | 7.7 urgency episodes STANDARD_DEVIATION 4.75 |
| Mean Urgency Incontinence Episodes / 24 hours | 2.0 urgency incontinence episodes STANDARD_DEVIATION 1.94 | 2.0 urgency incontinence episodes STANDARD_DEVIATION 1.96 | 1.9 urgency incontinence episodes STANDARD_DEVIATION 1.99 |
| Sex: Female, Male Female | 709 Participants | 1421 Participants | 712 Participants |
| Sex: Female, Male Male | 225 Participants | 449 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 936 | 54 / 934 |
| serious Total, serious adverse events | 14 / 936 | 13 / 934 |
Outcome results
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and final visit (up to Week 12)
Population: Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | -2.95 micturitions | Standard Error 0.087 |
| Solifenacin 5 mg | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | -3.13 micturitions | Standard Error 0.088 |
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 4 [N=877,871] | -0.72 nocturia episodes | Standard Error 0.033 |
| Mirabegron 50 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 8 [N=850,844] | -0.90 nocturia episodes | Standard Error 0.031 |
| Mirabegron 50 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 12 [N=831,828] | -0.98 nocturia episodes | Standard Error 0.032 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 4 [N=877,871] | -0.63 nocturia episodes | Standard Error 0.034 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 8 [N=850,844] | -0.87 nocturia episodes | Standard Error 0.031 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 12 [N=831,828] | -0.97 nocturia episodes | Standard Error 0.033 |
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and Week 4, Week 8 , Week 12
Population: FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 4 [M=574,563] | -1.80 pads | Standard Error 0.081 |
| Mirabegron 50 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 8 [N=551,543] | -2.10 pads | Standard Error 0.07 |
| Mirabegron 50 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 12 [N=543,532] | -2.14 pads | Standard Error 0.078 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 12 [N=543,532] | -2.20 pads | Standard Error 0.079 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 4 [M=574,563] | -1.82 pads | Standard Error 0.081 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Week 8 [N=551,543] | -2.14 pads | Standard Error 0.07 |
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 4 [N=916,906] | -0.36 units on a scale | Standard Error 0.016 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 12 [N=870,856] | -0.60 units on a scale | Standard Error 0.023 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 8 [N=888,876] | -0.50 units on a scale | Standard Error 0.019 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Final visit [N=920,910] | -0.58 units on a scale | Standard Error 0.022 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Final visit [N=920,910] | -0.57 units on a scale | Standard Error 0.022 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 4 [N=916,906] | -0.36 units on a scale | Standard Error 0.017 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 8 [N=888,876] | -0.52 units on a scale | Standard Error 0.019 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Week 12 [N=870,856] | -0.60 units on a scale | Standard Error 0.023 |
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 4 [N=915,905] | -3.75 urgency episodes | Standard Error 0.113 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 8 [N=887,875] | -4.44 urgency episodes | Standard Error 0.111 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 12 [N=869,855] | -4.67 urgency episodes | Standard Error 0.116 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Final Visit [N=919,909] | -4.61 urgency episodes | Standard Error 0.115 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Final Visit [N=919,909] | -4.84 urgency episodes | Standard Error 0.115 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 12 [N=869,855] | -4.99 urgency episodes | Standard Error 0.117 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 4 [N=915,905] | -3.88 urgency episodes | Standard Error 0.114 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Week 8 [N=887,875] | -4.79 urgency episodes | Standard Error 0.112 |
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS-I population. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 [N=404,410] | -1.22 incontinence episodes | Standard Error 0.063 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=387,397] | -1.37 incontinence episodes | Standard Error 0.093 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=381,387] | -1.41 incontinence episodes | Standard Error 0.115 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 [N=404,410] | -1.30 incontinence episodes | Standard Error 0.063 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=387,397] | -1.59 incontinence episodes | Standard Error 0.092 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=381,387] | -1.66 incontinence episodes | Standard Error 0.114 |
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and Week 4, Week 8, Week 12
Population: Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 4 [N=916,906] | -2.37 micturitions | Standard Error 0.083 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 8 [N=888,876] | -2.77 micturitions | Standard Error 0.084 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 12 [N=870,856] | -3.02 micturitions | Standard Error 0.088 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 4 [N=916,906] | -2.33 micturitions | Standard Error 0.083 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 8 [N=888,876] | -3.00 micturitions | Standard Error 0.085 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Week 12 [N=870,856] | -3.21 micturitions | Standard Error 0.089 |
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=395,399] | -1.22 urgency incontinence episodes | Standard Error 0.057 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=379,386] | -1.39 urgency incontinence episodes | Standard Error 0.05 |
| Mirabegron 50 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=373,377] | -1.49 urgency incontinence episodes | Standard Error 0.047 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=395,399] | -1.24 urgency incontinence episodes | Standard Error 0.057 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=379,386] | -1.56 urgency incontinence episodes | Standard Error 0.05 |
| Solifenacin 5 mg | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=373,377] | -1.59 urgency incontinence episodes | Standard Error 0.047 |
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and final visit (up to Week 12)
Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 38 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 133 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 55 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 52 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 92 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 22 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 55 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 332 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 356 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 52 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 121 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 83 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 68 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 45 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 29 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 35 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 18 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and final visit (up to Week 12)
Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 53 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 80 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 60 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 33 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 36 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 37 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 460 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 471 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 88 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 18 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 67 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 46 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 31 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 52 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and final visit (up to Week 12)
Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 39 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 116 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 80 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 51 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 103 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 48 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 30 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 55 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 297 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 306 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 52 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 118 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 93 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 83 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 72 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 44 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 14 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and final visit (up to Week 12)
Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 27 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 43 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 697 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 26 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 43 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 14 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 46 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 699 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and final visit (up to Week 12)
Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 31 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 106 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 83 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problem | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 42 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problem | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problem | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 29 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problem | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 46 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 444 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 440 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 49 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 113 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 54 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 79 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 41 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 14 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problem | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problem | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problem | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problem | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Time frame: Baseline and Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale | Week 12 [N=876,871] | 2.92 units on a scale | Standard Error 0.05 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale | Final visit [N=897,889] | 2.88 units on a scale | Standard Error 0.05 |
| Solifenacin 5 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale | Week 12 [N=876,871] | 3.07 units on a scale | Standard Error 0.05 |
| Solifenacin 5 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale | Final visit [N=897,889] | 3.03 units on a scale | Standard Error 0.05 |
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).
Time frame: Baseline and Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) | Week 12 [N=865,857] | 3.51 units on a scale | Standard Error 0.099 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) | Final visit [N=891,876] | 3.44 units on a scale | Standard Error 0.099 |
| Solifenacin 5 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) | Week 12 [N=865,857] | 3.93 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) | Final visit [N=891,876] | 3.86 units on a scale | Standard Error 0.1 |
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 12
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 38 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 132 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 52 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 51 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 84 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 18 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 53 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 323 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 341 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 48 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 118 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 80 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 67 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 44 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 28 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 35 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 14 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 12
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 43 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 35 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 18 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 77 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 57 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 442 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 36 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 31 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 53 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 82 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 32 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 51 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 63 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 43 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 30 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 459 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 25 participants |
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 12
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 39 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 112 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 79 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 49 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 97 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 42 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 29 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 50 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 287 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 299 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 49 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 116 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 87 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 18 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 80 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 71 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 38 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 12
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 36 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 667 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 44 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 43 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 13 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 23 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 36 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 42 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 46 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 670 participants |
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 12
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 31 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 27 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 103 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 81 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 41 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 43 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 425 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 426 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 45 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 22 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 107 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 53 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 79 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 31 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 40 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 4
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 32 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 98 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 64 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 122 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 37 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 29 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 59 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 328 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 339 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 65 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 102 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 94 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 33 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 65 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 40 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 29 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 19 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 4
Population: FAS population who have non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> moderate problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> slight problems | 47 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> severe problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> no problems | 39 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> slight problems | 39 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> no problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> moderate problems | 24 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> moderate problems | 50 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> severe problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> no problems | 66 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> no problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> slight problems | 24 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> No problems | 447 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Slight problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Moderate problems | 23 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Slight problems | 43 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Moderate problems | 19 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> Extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> no problems | 80 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> slight problems | 47 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Slight problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> no problems | 51 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> slight problems | 45 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> moderate problems | 46 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Moderate problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> no problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> slight problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> moderate problems | 29 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> severe problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Severe problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No data -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | No problems -> No problems | 443 participants |
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 4
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 60 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 299 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 57 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 101 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 116 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 32 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 51 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 66 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extrme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 21 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 22 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 19 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 65 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 97 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 19 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 109 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extrme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 285 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 67 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 44 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 86 participants |
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 4
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 13 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> No problems | 37 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 24 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 18 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 28 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> No problems | 693 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> No problems | 703 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 23 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> No problems | 41 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 17 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 28 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 4
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 21 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 102 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 47 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 59 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 49 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 61 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 421 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 422 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 63 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 101 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 58 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 59 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 39 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 28 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 19 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 8
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 11 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 50 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 325 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 52 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 42 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 122 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 94 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 31 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 23 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 39 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 49 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 59 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 37 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 334 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 65 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 116 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 79 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 2 participants |
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 8
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 30 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 14 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 30 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 21 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 70 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 51 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 41 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 46 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> modrate problems | 31 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 19 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 38 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 445 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 446 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 31 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 23 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 78 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 44 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 47 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 52 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> modrate problems | 40 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 22 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 41 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 8
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 13 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 103 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 111 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 25 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 59 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 66 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 46 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 37 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 18 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 291 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 52 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 66 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 57 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 286 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 10 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 96 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 103 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 30 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 61 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 78 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 25 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 1 participants |
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 8
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 672 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 35 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 20 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 42 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 19 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> exteme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 34 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 17 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 34 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 8 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 21 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 673 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 38 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 33 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 9 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> exteme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 0 participants |
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Time frame: Baseline and Week 8
Population: FAS population who has non-missing values at both Baseline and specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 430 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 48 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 15 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 16 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 45 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 101 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 61 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 57 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 13 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 23 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 7 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no data | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> moderate problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no problems | 426 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> slight problems | 49 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> slight problems | 32 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> moderate problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No problems -> no data | 13 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no problems | 109 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> slight problems | 50 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> extreme problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> moderate problems | 12 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> slight problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Severe problems -> no data | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Slight problems -> no data | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> no problems | 53 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no problems | 4 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> slight problems | 53 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> moderate problems | 20 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Extreme problems -> slight problems | 5 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Moderate problems -> severe problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | No data -> severe problems | 0 participants |
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 4 [N=905,896] | -0.91 units on a scale | Standard Error 0.035 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 8 [N=882,875] | -1.30 units on a scale | Standard Error 0.038 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=865,858] | -1.58 units on a scale | Standard Error 0.042 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Final visit [N=906,897] | -1.53 units on a scale | Standard Error 0.042 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Final visit [N=906,897] | -1.67 units on a scale | Standard Error 0.042 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 4 [N=905,896] | -1.00 units on a scale | Standard Error 0.035 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=865,858] | -1.73 units on a scale | Standard Error 0.042 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 8 [N=882,875] | -1.46 units on a scale | Standard Error 0.038 |
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 4 [N=905,896] | -20.51 units on a scale | Standard Error 0.576 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 8 [N=882,875] | -25.96 units on a scale | Standard Error 0.599 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 12 [N=865,859] | -29.74 units on a scale | Standard Error 0.647 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Final visit [N=906,897] | -28.89 units on a scale | Standard Error 0.652 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 12 [N=865,859] | -31.84 units on a scale | Standard Error 0.649 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Final visit [N=906,897] | -30.76 units on a scale | Standard Error 0.655 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 8 [N=882,875] | -27.76 units on a scale | Standard Error 0.601 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Week 4 [N=905,896] | -22.20 units on a scale | Standard Error 0.579 |
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 4 [N=905,896] | 17.09 units on a scale | Standard Error 0.543 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 8 [N=882,875] | 21.66 units on a scale | Standard Error 0.568 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 12 [N=865,859] | 25.31 units on a scale | Standard Error 0.611 |
| Mirabegron 50 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Final visit [N=906,897] | 24.53 units on a scale | Standard Error 0.616 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Final visit [N=906,897] | 25.94 units on a scale | Standard Error 0.619 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 4 [N=905,896] | 18.23 units on a scale | Standard Error 0.546 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 12 [N=865,859] | 26.85 units on a scale | Standard Error 0.613 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q | Week 8 [N=882,875] | 23.20 units on a scale | Standard Error 0.57 |
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=404,410] | 2.64 incontinence episodes | Standard Error 0.28 |
| Mirabegron 50 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=387,397] | 2.19 incontinence episodes | Standard Error 0.457 |
| Mirabegron 50 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=381,387] | 2.07 incontinence episodes | Standard Error 0.562 |
| Mirabegron 50 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=404,413] | 2.13 incontinence episodes | Standard Error 0.533 |
| Solifenacin 5 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=404,413] | 1.29 incontinence episodes | Standard Error 0.157 |
| Solifenacin 5 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=404,410] | 2.25 incontinence episodes | Standard Error 0.217 |
| Solifenacin 5 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=381,387] | 1.08 incontinence episodes | Standard Error 0.124 |
| Solifenacin 5 mg | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=387,397] | 1.28 incontinence episodes | Standard Error 0.135 |
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=877,871] | 4.78 nocturia episodes | Standard Error 0.12 |
| Mirabegron 50 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=850, 844] | 4.26 nocturia episodes | Standard Error 0.118 |
| Mirabegron 50 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=831,828] | 3.94 nocturia episodes | Standard Error 0.115 |
| Mirabegron 50 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final Visit [N=879,875] | 4.05 nocturia episodes | Standard Error 0.12 |
| Solifenacin 5 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final Visit [N=879,875] | 4.13 nocturia episodes | Standard Error 0.114 |
| Solifenacin 5 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=877,871] | 5.12 nocturia episodes | Standard Error 0.139 |
| Solifenacin 5 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=831,828] | 4.06 nocturia episodes | Standard Error 0.116 |
| Solifenacin 5 mg | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=850, 844] | 4.41 nocturia episodes | Standard Error 0.117 |
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=574,563] | 4.25 pads | Standard Error 0.324 |
| Mirabegron 50 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=551,543] | 3.33 pads | Standard Error 0.284 |
| Mirabegron 50 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=543,532] | 3.19 pads | Standard Error 0.304 |
| Mirabegron 50 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=576,565] | 3.32 pads | Standard Error 0.3 |
| Solifenacin 5 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=576,565] | 3.19 pads | Standard Error 0.248 |
| Solifenacin 5 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=574,563] | 4.26 pads | Standard Error 0.297 |
| Solifenacin 5 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=543,532] | 3.04 pads | Standard Error 0.244 |
| Solifenacin 5 mg | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=551,543] | 3.27 pads | Standard Error 0.236 |
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=395,399] | 2.27 urgency incontinence episodes | Standard Error 0.23 |
| Mirabegron 50 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=379,386] | 1.74 urgency incontinence episodes | Standard Error 0.227 |
| Mirabegron 50 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=373,377] | 1.44 urgency incontinence episodes | Standard Error 0.217 |
| Mirabegron 50 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=395,402] | 1.51 urgency incontinence episodes | Standard Error 0.211 |
| Solifenacin 5 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Final visit [N=395,402] | 1.23 urgency incontinence episodes | Standard Error 0.15 |
| Solifenacin 5 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4 [N=395,399] | 2.16 urgency incontinence episodes | Standard Error 0.213 |
| Solifenacin 5 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 12 [N=373,377] | 1.03 urgency incontinence episodes | Standard Error 0.12 |
| Solifenacin 5 mg | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 8 [N=379,386] | 1.13 urgency incontinence episodes | Standard Error 0.125 |
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Population: SAF population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Dry mouth | 3.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Blurred vision | 0.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Dry throat | 0.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Constipation | 2.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Overall | 5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Constipation | 2.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Overall | 7.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Dry mouth | 5.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Dry throat | 0.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | Blurred vision | 0.4 percentage of participants |
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4 [N=404,410] | 75.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 8 [N=387,397] | 85.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 12 [N=381,387] | 86.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Final visit [N=404,413] | 85.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Final visit [N=404,413] | 88.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4 [N=404,410] | 77.3 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 12 [N=381,387] | 89.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 8 [N=387,397] | 86.9 percentage of participants |
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline.
Time frame: Baseline to Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit | Week 12 [N=865,859] | 69.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit | Final visit [N=906,897] | 67.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit | Week 12 [N=865,859] | 72.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit | Final visit [N=906,897] | 71.0 percentage of participants |
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.
Time frame: Baseline to Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit | Week 12 [N=865,858] | 73.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit | Final visit [N=906,897] | 71.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit | Week 12 [N=865,858] | 76.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit | Final visit [N=906,897] | 74.9 percentage of participants |
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.
Time frame: Baseline to Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit | Week 12 [N=865,859] | 77.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit | Final visit [N=906,897] | 76.2 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit | Week 12 [N=865,859] | 82.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit | Final visit [N=906,897] | 81.2 percentage of participants |
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale.
Time frame: Baseline to final visit (up to Week 12)
Population: FAS population. LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥1 point improvement | 85.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥2 point improvement | 79.0 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥3 point improvement | 66.7 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥4 point improvement | 43.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥5 point improvement | 15.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | 6 point improvement | 2.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥5 point improvement | 15.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥1 point improvement | 89.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥4 point improvement | 46.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥2 point improvement | 82.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | 6 point improvement | 2.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit | ≥3 point improvement | 70.8 percentage of participants |
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.
Time frame: Baseline to Week 12
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥4 point improvement | 44.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥2 point improvement | 80.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥3 point improvement | 67.7 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥5 point improvement | 15.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | 6 point improvement | 2.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥1 point improvement | 86.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | 6 point improvement | 2.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥1 point improvement | 90.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥5 point improvement | 15.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥2 point improvement | 83.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥3 point improvement | 71.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 | ≥4 point improvement | 47.5 percentage of participants |
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.
Time frame: Baseline to Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit | Week 12 [N=865,858] | 47.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit | Final visit [N=906,897] | 46.2 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit | Week 12 [N=865,858] | 52.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit | Final visit [N=906,897] | 51.1 percentage of participants |
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0.
Time frame: Week 4, Week 8, Week 12
Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 4 [N=916,906] | 32.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 8 [N=888,876] | 41.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 12 [N=870,856] | 44.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Final visit [N=920,910] | 44.2 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Final visit [N=920,910] | 48.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 4 [N=916,906] | 33.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 12 [N=870,856] | 49.3 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 8 [N=888,876] | 46.9 percentage of participants |
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.
Time frame: Week 4, Week 8, Week 12
Population: FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4 [N=404,410] | 47.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 8 [N=387,397] | 64.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 12 [N=381,387] | 69.0 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Final visit [N=404,413] | 67.3 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Final visit [N=404,413] | 68.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4 [N=404,410] | 52.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 12 [N=381,387] | 69.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 8 [N=387,397] | 63.2 percentage of participants |