Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder (NCT NCT01340027)
NCT ID: NCT01340027
Last Updated: 2024-10-31
Results Overview
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1307 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-10-31
Participant Flow
Male and female patients with symptoms of overactive bladder (OAB; urgency, urinary frequency and/or urgency incontinence) for at least 3 months. The study was conducted at 141 sites in 20 countries in Europe.
After screening, 1658 participants entered a 2-week, single-blind, placebo run-in period. After completion of the run-in period, 1307 participants were randomly assigned to 1 of the 12 treatment arms in a 1:1:1:1:2:1:2:2:2:2:1:1 ratio.
Participant milestones
| Measure |
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
78
|
79
|
79
|
156
|
78
|
149
|
149
|
144
|
152
|
81
|
81
|
|
Overall Study
Received Treatment
|
81
|
78
|
78
|
79
|
156
|
78
|
149
|
149
|
144
|
152
|
81
|
81
|
|
Overall Study
COMPLETED
|
76
|
71
|
75
|
75
|
146
|
74
|
142
|
142
|
136
|
146
|
79
|
77
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
4
|
4
|
10
|
4
|
7
|
7
|
8
|
6
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but Never Received Study Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
1
|
2
|
2
|
1
|
4
|
1
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
0
|
6
|
0
|
0
|
1
|
2
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
1
|
3
|
3
|
2
|
3
|
4
|
1
|
2
|
0
|
1
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
Baseline characteristics by cohort
| Measure |
Placebo
n=81 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=77 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=78 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=79 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=156 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=78 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg +Mirabegron 25 mg
n=149 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=149 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=153 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=81 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=81 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Total
n=1306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 14.45 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.71 • n=4 Participants
|
54.2 years
STANDARD_DEVIATION 15.53 • n=21 Participants
|
55.0 years
STANDARD_DEVIATION 12.82 • n=10 Participants
|
55.8 years
STANDARD_DEVIATION 13.82 • n=115 Participants
|
53.7 years
STANDARD_DEVIATION 14.55 • n=24 Participants
|
55.0 years
STANDARD_DEVIATION 14.57 • n=42 Participants
|
54.1 years
STANDARD_DEVIATION 14.09 • n=42 Participants
|
56.5 years
STANDARD_DEVIATION 12.34 • n=42 Participants
|
55.5 years
STANDARD_DEVIATION 13.82 • n=42 Participants
|
54.8 years
STANDARD_DEVIATION 13.97 • n=36 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
100 Participants
n=115 Participants
|
100 Participants
n=24 Participants
|
95 Participants
n=42 Participants
|
101 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
867 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
49 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
439 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
81 participants
n=5 Participants
|
77 participants
n=7 Participants
|
78 participants
n=5 Participants
|
78 participants
n=4 Participants
|
156 participants
n=21 Participants
|
77 participants
n=10 Participants
|
149 participants
n=115 Participants
|
148 participants
n=24 Participants
|
143 participants
n=42 Participants
|
153 participants
n=42 Participants
|
81 participants
n=42 Participants
|
81 participants
n=42 Participants
|
1302 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
|
Type of Overactive Bladder (OAB)
Urge Incontinence
|
14 participants
n=5 Participants
|
27 participants
n=7 Participants
|
19 participants
n=5 Participants
|
18 participants
n=4 Participants
|
39 participants
n=21 Participants
|
19 participants
n=10 Participants
|
42 participants
n=115 Participants
|
33 participants
n=24 Participants
|
35 participants
n=42 Participants
|
35 participants
n=42 Participants
|
23 participants
n=42 Participants
|
20 participants
n=42 Participants
|
324 participants
n=36 Participants
|
|
Type of Overactive Bladder (OAB)
Mixed
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
27 participants
n=21 Participants
|
11 participants
n=10 Participants
|
22 participants
n=115 Participants
|
20 participants
n=24 Participants
|
19 participants
n=42 Participants
|
18 participants
n=42 Participants
|
14 participants
n=42 Participants
|
10 participants
n=42 Participants
|
180 participants
n=36 Participants
|
|
Type of Overactive Bladder (OAB)
Frequency
|
56 participants
n=5 Participants
|
39 participants
n=7 Participants
|
48 participants
n=5 Participants
|
50 participants
n=4 Participants
|
89 participants
n=21 Participants
|
48 participants
n=10 Participants
|
84 participants
n=115 Participants
|
95 participants
n=24 Participants
|
90 participants
n=42 Participants
|
100 participants
n=42 Participants
|
44 participants
n=42 Participants
|
50 participants
n=42 Participants
|
793 participants
n=36 Participants
|
|
Type of Overactive Bladder (OAB)
Missing
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
9 participants
n=36 Participants
|
|
Duration of OAB Symptoms
|
48.3 months
STANDARD_DEVIATION 38.37 • n=5 Participants
|
61.2 months
STANDARD_DEVIATION 68.03 • n=7 Participants
|
56.9 months
STANDARD_DEVIATION 66.62 • n=5 Participants
|
60.2 months
STANDARD_DEVIATION 67.85 • n=4 Participants
|
61.8 months
STANDARD_DEVIATION 78.21 • n=21 Participants
|
52.4 months
STANDARD_DEVIATION 56.98 • n=10 Participants
|
57.7 months
STANDARD_DEVIATION 68.91 • n=115 Participants
|
57.0 months
STANDARD_DEVIATION 66.85 • n=24 Participants
|
56.3 months
STANDARD_DEVIATION 84.78 • n=42 Participants
|
57.4 months
STANDARD_DEVIATION 81.53 • n=42 Participants
|
64.9 months
STANDARD_DEVIATION 100.57 • n=42 Participants
|
57.4 months
STANDARD_DEVIATION 80.12 • n=42 Participants
|
57.8 months
STANDARD_DEVIATION 73.82 • n=36 Participants
|
|
Mean Number of Micturitions per 24 Hours
|
10.36 micturitions
STANDARD_DEVIATION 2.036 • n=5 Participants
|
11.29 micturitions
STANDARD_DEVIATION 2.581 • n=7 Participants
|
10.78 micturitions
STANDARD_DEVIATION 2.254 • n=5 Participants
|
11.10 micturitions
STANDARD_DEVIATION 3.056 • n=4 Participants
|
11.34 micturitions
STANDARD_DEVIATION 3.158 • n=21 Participants
|
11.29 micturitions
STANDARD_DEVIATION 2.896 • n=10 Participants
|
11.25 micturitions
STANDARD_DEVIATION 3.643 • n=115 Participants
|
11.00 micturitions
STANDARD_DEVIATION 2.260 • n=24 Participants
|
10.92 micturitions
STANDARD_DEVIATION 2.386 • n=42 Participants
|
11.25 micturitions
STANDARD_DEVIATION 3.171 • n=42 Participants
|
11.14 micturitions
STANDARD_DEVIATION 2.268 • n=42 Participants
|
11.24 micturitions
STANDARD_DEVIATION 2.453 • n=42 Participants
|
11.10 micturitions
STANDARD_DEVIATION 2.794 • n=36 Participants
|
|
Mean Volume Voided per Micturition
|
156.4 mL
STANDARD_DEVIATION 52.80 • n=5 Participants
|
152.7 mL
STANDARD_DEVIATION 56.70 • n=7 Participants
|
156.8 mL
STANDARD_DEVIATION 52.33 • n=5 Participants
|
162.4 mL
STANDARD_DEVIATION 57.59 • n=4 Participants
|
145.5 mL
STANDARD_DEVIATION 59.34 • n=21 Participants
|
148.0 mL
STANDARD_DEVIATION 52.74 • n=10 Participants
|
156.8 mL
STANDARD_DEVIATION 61.97 • n=115 Participants
|
149.8 mL
STANDARD_DEVIATION 50.05 • n=24 Participants
|
155.0 mL
STANDARD_DEVIATION 55.55 • n=42 Participants
|
153.1 mL
STANDARD_DEVIATION 51.88 • n=42 Participants
|
141.4 mL
STANDARD_DEVIATION 51.29 • n=42 Participants
|
155.3 mL
STANDARD_DEVIATION 62.13 • n=42 Participants
|
152.5 mL
STANDARD_DEVIATION 55.65 • n=36 Participants
|
|
Mean Number of Urgency Episodes per 24 Hours
|
5.26 urgency episodes
STANDARD_DEVIATION 3.079 • n=5 Participants
|
6.25 urgency episodes
STANDARD_DEVIATION 3.332 • n=7 Participants
|
6.58 urgency episodes
STANDARD_DEVIATION 3.981 • n=5 Participants
|
6.20 urgency episodes
STANDARD_DEVIATION 3.870 • n=4 Participants
|
6.41 urgency episodes
STANDARD_DEVIATION 4.154 • n=21 Participants
|
6.37 urgency episodes
STANDARD_DEVIATION 4.530 • n=10 Participants
|
6.05 urgency episodes
STANDARD_DEVIATION 3.749 • n=115 Participants
|
6.78 urgency episodes
STANDARD_DEVIATION 3.419 • n=24 Participants
|
6.26 urgency episodes
STANDARD_DEVIATION 3.928 • n=42 Participants
|
6.49 urgency episodes
STANDARD_DEVIATION 4.238 • n=42 Participants
|
6.91 urgency episodes
STANDARD_DEVIATION 4.319 • n=42 Participants
|
6.81 urgency episodes
STANDARD_DEVIATION 4.312 • n=42 Participants
|
6.37 urgency episodes
STANDARD_DEVIATION 3.931 • n=36 Participants
|
|
Mean Level of Urgency
|
2.45 units on a scale
STANDARD_DEVIATION 0.503 • n=5 Participants
|
2.53 units on a scale
STANDARD_DEVIATION 0.439 • n=7 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 0.508 • n=5 Participants
|
2.53 units on a scale
STANDARD_DEVIATION 0.539 • n=4 Participants
|
2.49 units on a scale
STANDARD_DEVIATION 0.508 • n=21 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 0.503 • n=10 Participants
|
2.49 units on a scale
STANDARD_DEVIATION 0.445 • n=115 Participants
|
2.59 units on a scale
STANDARD_DEVIATION 0.446 • n=24 Participants
|
2.50 units on a scale
STANDARD_DEVIATION 0.491 • n=42 Participants
|
2.51 units on a scale
STANDARD_DEVIATION 0.441 • n=42 Participants
|
2.57 units on a scale
STANDARD_DEVIATION 0.493 • n=42 Participants
|
2.53 units on a scale
STANDARD_DEVIATION 0.473 • n=42 Participants
|
2.52 units on a scale
STANDARD_DEVIATION 0.479 • n=36 Participants
|
|
Mean Number of Nocturia Episodes per 24 Hours
|
2.19 nocturia episodes
STANDARD_DEVIATION 1.584 • n=5 Participants
|
2.18 nocturia episodes
STANDARD_DEVIATION 1.392 • n=7 Participants
|
2.31 nocturia episodes
STANDARD_DEVIATION 1.517 • n=5 Participants
|
2.46 nocturia episodes
STANDARD_DEVIATION 1.852 • n=4 Participants
|
2.19 nocturia episodes
STANDARD_DEVIATION 1.399 • n=21 Participants
|
2.50 nocturia episodes
STANDARD_DEVIATION 1.859 • n=10 Participants
|
2.64 nocturia episodes
STANDARD_DEVIATION 2.259 • n=115 Participants
|
2.05 nocturia episodes
STANDARD_DEVIATION 1.219 • n=24 Participants
|
2.28 nocturia episodes
STANDARD_DEVIATION 1.449 • n=42 Participants
|
2.27 nocturia episodes
STANDARD_DEVIATION 1.305 • n=42 Participants
|
2.65 nocturia episodes
STANDARD_DEVIATION 2.525 • n=42 Participants
|
2.41 nocturia episodes
STANDARD_DEVIATION 2.001 • n=42 Participants
|
2.33 nocturia episodes
STANDARD_DEVIATION 1.701 • n=36 Participants
|
|
Mean Number of Incontinence Episodes per 24 Hours
|
0.95 incontinence episodes
STANDARD_DEVIATION 0.765 • n=5 Participants
|
1.87 incontinence episodes
STANDARD_DEVIATION 1.578 • n=7 Participants
|
1.26 incontinence episodes
STANDARD_DEVIATION 1.000 • n=5 Participants
|
1.80 incontinence episodes
STANDARD_DEVIATION 1.167 • n=4 Participants
|
1.33 incontinence episodes
STANDARD_DEVIATION 1.242 • n=21 Participants
|
1.40 incontinence episodes
STANDARD_DEVIATION 1.280 • n=10 Participants
|
1.27 incontinence episodes
STANDARD_DEVIATION 1.096 • n=115 Participants
|
1.14 incontinence episodes
STANDARD_DEVIATION 0.791 • n=24 Participants
|
1.24 incontinence episodes
STANDARD_DEVIATION 1.108 • n=42 Participants
|
1.17 incontinence episodes
STANDARD_DEVIATION 1.196 • n=42 Participants
|
1.53 incontinence episodes
STANDARD_DEVIATION 1.235 • n=42 Participants
|
1.25 incontinence episodes
STANDARD_DEVIATION 0.858 • n=42 Participants
|
1.31 incontinence episodes
STANDARD_DEVIATION 1.109 • n=36 Participants
|
|
Mean Number of Urgency Incontinence Episodes per 24 Hours
|
0.78 urgency incontinence episodes
STANDARD_DEVIATION 0.807 • n=5 Participants
|
1.54 urgency incontinence episodes
STANDARD_DEVIATION 1.337 • n=7 Participants
|
1.19 urgency incontinence episodes
STANDARD_DEVIATION 1.043 • n=5 Participants
|
1.56 urgency incontinence episodes
STANDARD_DEVIATION 1.052 • n=4 Participants
|
1.32 urgency incontinence episodes
STANDARD_DEVIATION 1.227 • n=21 Participants
|
1.18 urgency incontinence episodes
STANDARD_DEVIATION 1.308 • n=10 Participants
|
0.96 urgency incontinence episodes
STANDARD_DEVIATION 0.903 • n=115 Participants
|
1.06 urgency incontinence episodes
STANDARD_DEVIATION 0.757 • n=24 Participants
|
1.23 urgency incontinence episodes
STANDARD_DEVIATION 1.118 • n=42 Participants
|
1.08 urgency incontinence episodes
STANDARD_DEVIATION 1.193 • n=42 Participants
|
1.51 urgency incontinence episodes
STANDARD_DEVIATION 1.247 • n=42 Participants
|
1.20 urgency incontinence episodes
STANDARD_DEVIATION 0.901 • n=42 Participants
|
1.20 urgency incontinence episodes
STANDARD_DEVIATION 1.072 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
|
14.0 mL
Standard Error 5.91
|
24.9 mL
Standard Error 6.06
|
34.5 mL
Standard Error 6.02
|
36.4 mL
Standard Error 6.02
|
36.0 mL
Standard Error 4.32
|
36.2 mL
Standard Error 6.06
|
39.4 mL
Standard Error 4.37
|
41.9 mL
Standard Error 4.36
|
53.6 mL
Standard Error 4.45
|
54.2 mL
Standard Error 4.31
|
57.6 mL
Standard Error 5.99
|
62.3 mL
Standard Error 5.90
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; LOCF was used.
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
|
-2.43 micturitions
Standard Error 0.291
|
-2.48 micturitions
Standard Error 0.298
|
-2.56 micturitions
Standard Error 0.296
|
-2.44 micturitions
Standard Error 0.296
|
-2.54 micturitions
Standard Error 0.212
|
-3.22 micturitions
Standard Error 0.298
|
-2.58 micturitions
Standard Error 0.215
|
-2.93 micturitions
Standard Error 0.215
|
-2.56 micturitions
Standard Error 0.219
|
-3.34 micturitions
Standard Error 0.212
|
-3.42 micturitions
Standard Error 0.294
|
-3.52 micturitions
Standard Error 0.291
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=13 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=18 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=15 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=35 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=15 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=35 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=33 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=32 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=24 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=24 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=20 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
|
-0.95 incontinence episodes
Standard Error 0.365
|
-0.74 incontinence episodes
Standard Error 0.415
|
-0.90 incontinence episodes
Standard Error 0.353
|
-1.26 incontinence episodes
Standard Error 0.386
|
-0.88 incontinence episodes
Standard Error 0.252
|
-0.97 incontinence episodes
Standard Error 0.386
|
-0.75 incontinence episodes
Standard Error 0.251
|
-0.85 incontinence episodes
Standard Error 0.260
|
-1.22 incontinence episodes
Standard Error 0.266
|
-1.14 incontinence episodes
Standard Error 0.306
|
-0.27 incontinence episodes
Standard Error 0.304
|
-0.97 incontinence episodes
Standard Error 0.333
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n")..
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75
|
10.2 mL
Standard Error 4.93
|
16.8 mL
Standard Error 5.16
|
29.4 mL
Standard Error 5.09
|
24.8 mL
Standard Error 5.02
|
29.6 mL
Standard Error 3.63
|
28.3 mL
Standard Error 5.16
|
29.2 mL
Standard Error 3.69
|
36.5 mL
Standard Error 3.67
|
42.7 mL
Standard Error 3.73
|
44.5 mL
Standard Error 3.65
|
45.7 mL
Standard Error 5.00
|
54.5 mL
Standard Error 5.06
|
|
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74
|
13.5 mL
Standard Error 5.56
|
24.6 mL
Standard Error 5.83
|
35.4 mL
Standard Error 5.71
|
28.3 mL
Standard Error 5.63
|
30.1 mL
Standard Error 4.03
|
37.7 mL
Standard Error 5.71
|
35.6 mL
Standard Error 4.08
|
42.3 mL
Standard Error 4.09
|
49.7 mL
Standard Error 4.21
|
52.2 mL
Standard Error 4.08
|
55.8 mL
Standard Error 5.60
|
68.5 mL
Standard Error 5.67
|
|
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77
|
8.7 mL
Standard Error 4.44
|
14.3 mL
Standard Error 4.71
|
26.0 mL
Standard Error 4.55
|
22.7 mL
Standard Error 4.62
|
23.1 mL
Standard Error 3.26
|
16.1 mL
Standard Error 4.64
|
22.5 mL
Standard Error 3.30
|
29.2 mL
Standard Error 3.30
|
29.9 mL
Standard Error 3.40
|
32.3 mL
Standard Error 3.34
|
29.5 mL
Standard Error 4.56
|
42.1 mL
Standard Error 4.52
|
|
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73
|
14.7 mL
Standard Error 6.12
|
23.0 mL
Standard Error 6.43
|
35.5 mL
Standard Error 6.20
|
36.9 mL
Standard Error 6.20
|
34.6 mL
Standard Error 4.42
|
35.8 mL
Standard Error 6.25
|
38.6 mL
Standard Error 4.52
|
43.7 mL
Standard Error 4.51
|
54.7 mL
Standard Error 4.60
|
56.6 mL
Standard Error 4.48
|
59.8 mL
Standard Error 6.26
|
66.2 mL
Standard Error 6.20
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n").
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77
|
-1.18 micturitions
Standard Error 0.240
|
-1.69 micturitions
Standard Error 0.255
|
-1.60 micturitions
Standard Error 0.246
|
-1.49 micturitions
Standard Error 0.249
|
-1.16 micturitions
Standard Error 0.176
|
-1.32 micturitions
Standard Error 0.251
|
-1.52 micturitions
Standard Error 0.178
|
-1.95 micturitions
Standard Error 0.178
|
-1.68 micturitions
Standard Error 0.184
|
-2.21 micturitions
Standard Error 0.181
|
-1.74 micturitions
Standard Error 0.244
|
-2.35 micturitions
Standard Error 0.244
|
|
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75
|
-1.68 micturitions
Standard Error 0.261
|
-2.02 micturitions
Standard Error 0.273
|
-1.99 micturitions
Standard Error 0.269
|
-2.10 micturitions
Standard Error 0.266
|
-1.80 micturitions
Standard Error 0.191
|
-2.25 micturitions
Standard Error 0.271
|
-2.03 micturitions
Standard Error 0.195
|
-2.11 micturitions
Standard Error 0.194
|
-2.29 micturitions
Standard Error 0.197
|
-2.77 micturitions
Standard Error 0.193
|
-2.55 micturitions
Standard Error 0.264
|
-2.69 micturitions
Standard Error 0.267
|
|
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74
|
-2.27 micturitions
Standard Error 0.270
|
-2.27 micturitions
Standard Error 0.283
|
-2.42 micturitions
Standard Error 0.277
|
-2.46 micturitions
Standard Error 0.273
|
-2.22 micturitions
Standard Error 0.196
|
-2.97 micturitions
Standard Error 0.275
|
-2.58 micturitions
Standard Error 0.198
|
-2.66 micturitions
Standard Error 0.199
|
-2.43 micturitions
Standard Error 0.205
|
-3.20 micturitions
Standard Error 0.197
|
-3.04 micturitions
Standard Error 0.270
|
-3.49 micturitions
Standard Error 0.275
|
|
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73
|
-2.59 micturitions
Standard Error 0.302
|
-2.51 micturitions
Standard Error 0.314
|
-2.67 micturitions
Standard Error 0.306
|
-2.38 micturitions
Standard Error 0.306
|
-2.58 micturitions
Standard Error 0.218
|
-3.31 micturitions
Standard Error 0.306
|
-2.64 micturitions
Standard Error 0.222
|
-3.02 micturitions
Standard Error 0.222
|
-2.64 micturitions
Standard Error 0.227
|
-3.35 micturitions
Standard Error 0.218
|
-3.47 micturitions
Standard Error 0.302
|
-3.63 micturitions
Standard Error 0.306
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Micturition Response
Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74
|
42.3 percentage of participants
|
27.8 percentage of participants
|
43.8 percentage of participants
|
35.6 percentage of participants
|
34.0 percentage of participants
|
44.4 percentage of participants
|
45.3 percentage of participants
|
42.1 percentage of participants
|
48.2 percentage of participants
|
56.4 percentage of participants
|
48.1 percentage of participants
|
41.9 percentage of participants
|
|
Percentage of Participants With a Micturition Response
Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76
|
27.8 percentage of participants
|
25.7 percentage of participants
|
37.3 percentage of participants
|
29.6 percentage of participants
|
26.4 percentage of participants
|
34.7 percentage of participants
|
36.4 percentage of participants
|
38.5 percentage of participants
|
34.1 percentage of participants
|
36.5 percentage of participants
|
36.4 percentage of participants
|
46.1 percentage of participants
|
|
Percentage of Participants With a Micturition Response
Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73
|
53.9 percentage of participants
|
35.7 percentage of participants
|
50.7 percentage of participants
|
43.1 percentage of participants
|
40.0 percentage of participants
|
56.2 percentage of participants
|
46.8 percentage of participants
|
54.3 percentage of participants
|
49.6 percentage of participants
|
56.3 percentage of participants
|
57.1 percentage of participants
|
64.4 percentage of participants
|
|
Percentage of Participants With a Micturition Response
Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72
|
55.4 percentage of participants
|
46.4 percentage of participants
|
47.2 percentage of participants
|
53.6 percentage of participants
|
47.9 percentage of participants
|
55.6 percentage of participants
|
55.1 percentage of participants
|
55.1 percentage of participants
|
53.8 percentage of participants
|
62.0 percentage of participants
|
65.3 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With a Micturition Response
EOT; n=79,75,76,73,146,75,144,145,140,146,78,79
|
53.2 percentage of participants
|
42.7 percentage of participants
|
47.4 percentage of participants
|
54.8 percentage of participants
|
47.9 percentage of participants
|
54.7 percentage of participants
|
54.2 percentage of participants
|
53.1 percentage of participants
|
52.1 percentage of participants
|
61.6 percentage of participants
|
65.4 percentage of participants
|
58.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n").
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=13 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=18 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=15 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=35 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=15 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=35 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=33 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=32 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=24 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=24 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=19 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
|
-0.87 incontinence episodes
Standard Error 0.146
|
-0.48 incontinence episodes
Standard Error 0.189
|
-0.89 incontinence episodes
Standard Error 0.141
|
-1.20 incontinence episodes
Standard Error 0.155
|
-0.80 incontinence episodes
Standard Error 0.102
|
-0.84 incontinence episodes
Standard Error 0.160
|
-0.73 incontinence episodes
Standard Error 0.102
|
-0.67 incontinence episodes
Standard Error 0.109
|
-0.81 incontinence episodes
Standard Error 0.106
|
-0.88 incontinence episodes
Standard Error 0.125
|
-1.18 incontinence episodes
Standard Error 0.122
|
-0.71 incontinence episodes
Standard Error 0.137
|
|
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
|
-0.82 incontinence episodes
Standard Error 0.163
|
-0.65 incontinence episodes
Standard Error 0.210
|
-0.92 incontinence episodes
Standard Error 0.157
|
-1.12 incontinence episodes
Standard Error 0.178
|
-0.72 incontinence episodes
Standard Error 0.114
|
-1.04 incontinence episodes
Standard Error 0.172
|
-0.78 incontinence episodes
Standard Error 0.112
|
-0.82 incontinence episodes
Standard Error 0.122
|
-1.01 incontinence episodes
Standard Error 0.118
|
-0.95 incontinence episodes
Standard Error 0.142
|
-0.93 incontinence episodes
Standard Error 0.136
|
-0.91 incontinence episodes
Standard Error 0.149
|
|
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
|
-0.93 incontinence episodes
Standard Error 0.373
|
-0.59 incontinence episodes
Standard Error 0.482
|
-0.89 incontinence episodes
Standard Error 0.361
|
-1.21 incontinence episodes
Standard Error 0.424
|
-0.84 incontinence episodes
Standard Error 0.261
|
-0.95 incontinence episodes
Standard Error 0.409
|
-0.74 incontinence episodes
Standard Error 0.265
|
-0.88 incontinence episodes
Standard Error 0.279
|
-1.20 incontinence episodes
Standard Error 0.280
|
-1.11 incontinence episodes
Standard Error 0.319
|
-0.27 incontinence episodes
Standard Error 0.311
|
-0.96 incontinence episodes
Standard Error 0.341
|
|
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
|
-0.83 incontinence episodes
Standard Error 0.168
|
-0.43 incontinence episodes
Standard Error 0.191
|
-0.85 incontinence episodes
Standard Error 0.162
|
-0.98 incontinence episodes
Standard Error 0.178
|
-0.67 incontinence episodes
Standard Error 0.119
|
-0.71 incontinence episodes
Standard Error 0.184
|
-0.49 incontinence episodes
Standard Error 0.116
|
-0.64 incontinence episodes
Standard Error 0.120
|
-0.70 incontinence episodes
Standard Error 0.122
|
-0.65 incontinence episodes
Standard Error 0.150
|
-1.14 incontinence episodes
Standard Error 0.140
|
-0.77 incontinence episodes
Standard Error 0.157
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=13 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=18 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=15 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=35 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=15 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=35 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=33 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=32 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=24 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=24 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=20 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Zero Incontinence Episodes Post-baseline
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
|
47.1 percentage of participants
|
23.1 percentage of participants
|
44.4 percentage of participants
|
40.0 percentage of participants
|
45.5 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
51.5 percentage of participants
|
65.6 percentage of participants
|
52.4 percentage of participants
|
70.8 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants With Zero Incontinence Episodes Post-baseline
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
|
64.7 percentage of participants
|
20.0 percentage of participants
|
55.6 percentage of participants
|
73.3 percentage of participants
|
64.7 percentage of participants
|
71.4 percentage of participants
|
55.9 percentage of participants
|
46.7 percentage of participants
|
62.5 percentage of participants
|
52.2 percentage of participants
|
79.2 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants With Zero Incontinence Episodes Post-baseline
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
|
82.4 percentage of participants
|
46.2 percentage of participants
|
61.1 percentage of participants
|
66.7 percentage of participants
|
60.0 percentage of participants
|
53.3 percentage of participants
|
54.3 percentage of participants
|
60.6 percentage of participants
|
87.5 percentage of participants
|
87.5 percentage of participants
|
79.2 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Zero Incontinence Episodes Post-baseline
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
|
58.8 percentage of participants
|
50.0 percentage of participants
|
61.1 percentage of participants
|
71.4 percentage of participants
|
50.0 percentage of participants
|
73.3 percentage of participants
|
54.3 percentage of participants
|
50.0 percentage of participants
|
71.9 percentage of participants
|
77.3 percentage of participants
|
79.2 percentage of participants
|
65.0 percentage of participants
|
|
Percentage of Participants With Zero Incontinence Episodes Post-baseline
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
|
82.4 percentage of participants
|
50.0 percentage of participants
|
61.1 percentage of participants
|
69.2 percentage of participants
|
58.8 percentage of participants
|
57.1 percentage of participants
|
51.5 percentage of participants
|
63.3 percentage of participants
|
86.7 percentage of participants
|
87.0 percentage of participants
|
79.2 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by "n"); LOCF imputation was used for the End of Treatment (EOT) analysis.
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=13 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=18 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=15 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=35 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=15 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=35 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=33 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=32 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=24 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=24 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=20 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With 50% Reduction in Incontinence Episodes
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19
|
64.7 percentage of participants
|
30.8 percentage of participants
|
66.7 percentage of participants
|
73.3 percentage of participants
|
57.6 percentage of participants
|
57.1 percentage of participants
|
51.4 percentage of participants
|
66.7 percentage of participants
|
71.9 percentage of participants
|
66.7 percentage of participants
|
91.7 percentage of participants
|
68.4 percentage of participants
|
|
Percentage of Participants With 50% Reduction in Incontinence Episodes
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19
|
82.4 percentage of participants
|
40.0 percentage of participants
|
72.2 percentage of participants
|
86.7 percentage of participants
|
76.5 percentage of participants
|
78.6 percentage of participants
|
64.7 percentage of participants
|
63.3 percentage of participants
|
75.0 percentage of participants
|
78.3 percentage of participants
|
95.8 percentage of participants
|
68.4 percentage of participants
|
|
Percentage of Participants With 50% Reduction in Incontinence Episodes
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20
|
76.5 percentage of participants
|
60.0 percentage of participants
|
77.8 percentage of participants
|
85.7 percentage of participants
|
58.8 percentage of participants
|
86.7 percentage of participants
|
82.9 percentage of participants
|
73.3 percentage of participants
|
90.6 percentage of participants
|
81.8 percentage of participants
|
91.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With 50% Reduction in Incontinence Episodes
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
|
94.1 percentage of participants
|
70.0 percentage of participants
|
77.8 percentage of participants
|
84.6 percentage of participants
|
73.5 percentage of participants
|
64.3 percentage of participants
|
66.7 percentage of participants
|
80.0 percentage of participants
|
96.7 percentage of participants
|
95.7 percentage of participants
|
95.8 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With 50% Reduction in Incontinence Episodes
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
|
94.1 percentage of participants
|
61.5 percentage of participants
|
77.8 percentage of participants
|
86.7 percentage of participants
|
74.3 percentage of participants
|
66.7 percentage of participants
|
68.6 percentage of participants
|
75.8 percentage of participants
|
96.9 percentage of participants
|
95.8 percentage of participants
|
95.8 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=13 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=18 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=15 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=35 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=15 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=35 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=33 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=32 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=24 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=24 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=20 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18
|
-0.80 urgency incontinence episodes
Standard Error 0.178
|
-0.59 urgency incontinence episodes
Standard Error 0.184
|
-0.83 urgency incontinence episodes
Standard Error 0.161
|
-0.96 urgency incontinence episodes
Standard Error 0.171
|
-0.66 urgency incontinence episodes
Standard Error 0.115
|
-0.77 urgency incontinence episodes
Standard Error 0.191
|
-0.52 urgency incontinence episodes
Standard Error 0.123
|
-0.68 urgency incontinence episodes
Standard Error 0.115
|
-0.68 urgency incontinence episodes
Standard Error 0.120
|
-0.64 urgency incontinence episodes
Standard Error 0.145
|
-1.12 urgency incontinence episodes
Standard Error 0.135
|
-0.76 urgency incontinence episodes
Standard Error 0.156
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18
|
-0.83 urgency incontinence episodes
Standard Error 0.157
|
-0.48 urgency incontinence episodes
Standard Error 0.185
|
-0.93 urgency incontinence episodes
Standard Error 0.142
|
-1.13 urgency incontinence episodes
Standard Error 0.151
|
-0.77 urgency incontinence episodes
Standard Error 0.100
|
-1.00 urgency incontinence episodes
Standard Error 0.169
|
-0.73 urgency incontinence episodes
Standard Error 0.111
|
-0.70 urgency incontinence episodes
Standard Error 0.107
|
-0.81 urgency incontinence episodes
Standard Error 0.106
|
-0.86 urgency incontinence episodes
Standard Error 0.125
|
-1.20 urgency incontinence episodes
Standard Error 0.120
|
-0.68 urgency incontinence episodes
Standard Error 0.138
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19
|
-0.86 urgency incontinence episodes
Standard Error 0.173
|
-0.65 urgency incontinence episodes
Standard Error 0.204
|
-1.00 urgency incontinence episodes
Standard Error 0.157
|
-1.04 urgency incontinence episodes
Standard Error 0.172
|
-0.76 urgency incontinence episodes
Standard Error 0.110
|
-1.16 urgency incontinence episodes
Standard Error 0.179
|
-0.86 urgency incontinence episodes
Standard Error 0.119
|
-0.84 urgency incontinence episodes
Standard Error .118
|
-0.99 urgency incontinence episodes
Standard Error 0.117
|
-0.89 urgency incontinence episodes
Standard Error 0.141
|
-0.91 urgency incontinence episodes
Standard Error 0.132
|
-0.88 urgency incontinence episodes
Standard Error 0.148
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19
|
-0.84 urgency incontinence episodes
Standard Error 0.420
|
-0.54 urgency incontinence episodes
Standard Error 0.493
|
-0.87 urgency incontinence episodes
Standard Error 0.379
|
-1.13 urgency incontinence episodes
Standard Error 0.433
|
-0.83 urgency incontinence episodes
Standard Error 0.267
|
-1.13 urgency incontinence episodes
Standard Error 0.451
|
-0.81 urgency incontinence episodes
Standard Error 0.295
|
-0.91 urgency incontinence episodes
Standard Error 0.286
|
-1.19 urgency incontinence episodes
Standard Error 0.292
|
-1.06 urgency incontinence episodes
Standard Error 0.334
|
-0.28 urgency incontinence episodes
Standard Error 0.319
|
-0.93 urgency incontinence episodes
Standard Error 0.358
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
EOT; n=14,13,17,15,35,13,29,33,31,23,24,19
|
-0.86 urgency incontinence episodes
Standard Error 0.411
|
-0.80 urgency incontinence episodes
Standard Error 0.424
|
-0.88 urgency incontinence episodes
Standard Error 0.372
|
-1.17 urgency incontinence episodes
Standard Error 0.394
|
-0.86 urgency incontinence episodes
Standard Error 0.258
|
-1.13 urgency incontinence episodes
Standard Error 0.424
|
-0.81 urgency incontinence episodes
Standard Error 0.283
|
-0.87 urgency incontinence episodes
Standard Error 0.266
|
-1.20 urgency incontinence episodes
Standard Error 0.277
|
-1.08 urgency incontinence episodes
Standard Error 0.321
|
-0.28 urgency incontinence episodes
Standard Error 0.312
|
-0.94 urgency incontinence episodes
Standard Error 0.351
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77
|
-2.07 urgency episodes
Standard Error 0.276
|
-2.06 urgency episodes
Standard Error 0.292
|
-1.91 urgency episodes
Standard Error 0.282
|
-2.49 urgency episodes
Standard Error 0.286
|
-1.63 urgency episodes
Standard Error 0.202
|
-1.97 urgency episodes
Standard Error 0.288
|
-1.84 urgency episodes
Standard Error 0.205
|
-2.59 urgency episodes
Standard Error 0.205
|
-2.30 urgency episodes
Standard Error 0.211
|
-2.57 urgency episodes
Standard Error 0.207
|
-2.35 urgency episodes
Standard Error 0.281
|
-2.23 urgency episodes
Standard Error 0.281
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75
|
-2.55 urgency episodes
Standard Error 0.308
|
-2.70 urgency episodes
Standard Error 0.322
|
-2.70 urgency episodes
Standard Error 0.317
|
-3.16 urgency episodes
Standard Error 0.313
|
-2.24 urgency episodes
Standard Error 0.225
|
-3.02 urgency episodes
Standard Error 0.320
|
-2.64 urgency episodes
Standard Error 0.230
|
-3.14 urgency episodes
Standard Error 0.229
|
-3.08 urgency episodes
Standard Error 0.233
|
-3.17 urgency episodes
Standard Error 0.228
|
-3.04 urgency episodes
Standard Error 0.311
|
-2.81 urgency episodes
Standard Error 0.316
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74
|
-3.42 urgency episodes
Standard Error 0.318
|
-2.86 urgency episodes
Standard Error 0.332
|
-3.27 urgency episodes
Standard Error 0.325
|
-3.61 urgency episodes
Standard Error 0.321
|
-2.67 urgency episodes
Standard Error 0.229
|
-3.63 urgency episodes
Standard Error 0.323
|
-3.34 urgency episodes
Standard Error 0.232
|
-3.60 urgency episodes
Standard Error 0.233
|
-3.60 urgency episodes
Standard Error 0.240
|
-3.85 urgency episodes
Standard Error 0.231
|
-3.53 urgency episodes
Standard Error 0.317
|
-3.63 urgency episodes
Standard Error 0.323
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73
|
-3.69 urgency episodes
Standard Error 0.334
|
-3.31 urgency episodes
Standard Error 0.347
|
-3.65 urgency episodes
Standard Error 0.338
|
-3.54 urgency episodes
Standard Error 0.338
|
-2.71 urgency episodes
Standard Error 0.240
|
-4.15 urgency episodes
Standard Error 0.337
|
-3.26 urgency episodes
Standard Error 0.246
|
-4.24 urgency episodes
Standard Error 0.246
|
-3.98 urgency episodes
Standard Error 0.250
|
-4.09 urgency episodes
Standard Error 0.240
|
-3.76 urgency episodes
Standard Error 0.333
|
-3.93 urgency episodes
Standard Error 0.338
|
|
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
EOT; n=80,76,77,77,150,76,146,147,141,150,78,80
|
-3.53 urgency episodes
Standard Error 0.328
|
-3.23 urgency episodes
Standard Error 0.336
|
-3.44 urgency episodes
Standard Error 0.334
|
-3.62 urgency episodes
Standard Error 0.334
|
-2.73 urgency episodes
Standard Error 0.239
|
-3.98 urgency episodes
Standard Error 0.336
|
-3.21 urgency episodes
Standard Error 0.242
|
-3.97 urgency episodes
Standard Error 0.242
|
-3.86 urgency episodes
Standard Error 0.247
|
-4.10 urgency episodes
Standard Error 0.239
|
-3.71 urgency episodes
Standard Error 0.332
|
-3.91 urgency episodes
Standard Error 0.327
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Level of Urgency
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74
|
-0.42 units on a scale
Standard Error 0.059
|
-0.30 units on a scale
Standard Error 0.062
|
-0.36 units on a scale
Standard Error 0.061
|
-0.45 units on a scale
Standard Error 0.060
|
-0.30 units on a scale
Standard Error 0.043
|
-0.44 units on a scale
Standard Error 0.60
|
-0.39 units on a scale
Standard Error 0.043
|
-0.41 units on a scale
Standard Error 0.044
|
-0.45 units on a scale
Standard Error 0.045
|
-0.46 units on a scale
Standard Error 0.043
|
-0.53 units on a scale
Standard Error 0.059
|
-0.43 units on a scale
Standard Error 0.060
|
|
Change From Baseline to Each Visit in Mean Level of Urgency
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77
|
-0.24 units on a scale
Standard Error 0.043
|
-0.19 units on a scale
Standard Error 0.046
|
-0.15 units on a scale
Standard Error 0.044
|
-0.25 units on a scale
Standard Error 0.045
|
-0.14 units on a scale
Standard Error 0.032
|
-0.21 units on a scale
Standard Error 0.045
|
-0.19 units on a scale
Standard Error 0.032
|
-0.26 units on a scale
Standard Error 0.032
|
-0.26 units on a scale
Standard Error 0.033
|
-0.28 units on a scale
Standard Error 0.033
|
-0.31 units on a scale
Standard Error 0.044
|
-0.20 units on a scale
Standard Error 0.044
|
|
Change From Baseline to Each Visit in Mean Level of Urgency
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75
|
-0.32 units on a scale
Standard Error 0.052
|
-0.28 units on a scale
Standard Error 0.054
|
-0.26 units on a scale
Standard Error 0.053
|
-0.33 units on a scale
Standard Error 0.053
|
-0.23 units on a scale
Standard Error 0.038
|
-0.35 units on a scale
Standard Error 0.054
|
-0.32 units on a scale
Standard Error 0.039
|
-0.35 units on a scale
Standard Error 0.039
|
-0.35 units on a scale
Standard Error 0.039
|
-0.37 units on a scale
Standard Error 0.038
|
-0.41 units on a scale
Standard Error 0.052
|
-0.31 units on a scale
Standard Error 0.053
|
|
Change From Baseline to Each Visit in Mean Level of Urgency
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73
|
-0.48 units on a scale
Standard Error 0.064
|
-0.35 units on a scale
Standard Error 0.067
|
-0.44 units on a scale
Standard Error 0.065
|
-0.42 units on a scale
Standard Error 0.065
|
-0.33 units on a scale
Standard Error 0.046
|
-0.49 units on a scale
Standard Error 0.065
|
-0.43 units on a scale
Standard Error 0.047
|
-0.54 units on a scale
Standard Error 0.047
|
-0.50 units on a scale
Standard Error 0.048
|
-0.54 units on a scale
Standard Error 0.046
|
-0.61 units on a scale
Standard Error 0.064
|
-0.49 units on a scale
Standard Error 0.065
|
|
Change From Baseline to Each Visit in Mean Level of Urgency
EOT; n=80,76,77,77,150,76,146,147,141,150,78,80
|
-0.46 units on a scale
Standard Error 0.063
|
-0.33 units on a scale
Standard Error 0.064
|
-0.41 units on a scale
Standard Error 0.064
|
-0.45 units on a scale
Standard Error 0.064
|
-0.33 units on a scale
Standard Error 0.064
|
-0.47 units on a scale
Standard Error 0.064
|
-0.42 units on a scale
Standard Error 0.046
|
-0.50 units on a scale
Standard Error 0.046
|
-0.48 units on a scale
Standard Error 0.047
|
-0.55 units on a scale
Standard Error 0.046
|
-0.59 units on a scale
Standard Error 0.063
|
-0.47 units on a scale
Standard Error 0.063
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
EOT; n=33,34,35,32,76,24,63,56,64,65,46,32
|
-0.63 pads
Standard Error 0.244
|
-1.04 pads
Standard Error 0.241
|
-0.95 pads
Standard Error 0.237
|
-1.44 pads
Standard Error 0.248
|
-1.38 pads
Standard Error 0.161
|
-1.73 pads
Standard Error 0.287
|
-1.04 pads
Standard Error 0.177
|
-1.38 pads
Standard Error 0.188
|
-1.46 pads
Standard Error 0.176
|
-1.63 pads
Standard Error 0.174
|
-1.59 pads
Standard Error 0.207
|
-1.63 pads
Standard Error 0.248
|
|
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30
|
-0.81 pads
Standard Error 0.212
|
-0.87 pads
Standard Error 0.212
|
-0.88 pads
Standard Error 0.209
|
-1.31 pads
Standard Error 0.219
|
-0.92 pads
Standard Error 0.142
|
-0.91 pads
Standard Error 0.255
|
-0.86 pads
Standard Error 0.155
|
-0.96 pads
Standard Error 0.164
|
-0.89 pads
Standard Error 0.155
|
-1.02 pads
Standard Error 0.155
|
-1.13 pads
Standard Error 0.182
|
-1.31 pads
Standard Error 0.223
|
|
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30
|
-0.76 pads
Standard Error 0.224
|
-0.93 pads
Standard Error 0.228
|
-0.70 pads
Standard Error 0.214
|
-1.62 pads
Standard Error 0.228
|
-1.26 pads
Standard Error 0.147
|
-1.23 pads
Standard Error 0.265
|
-0.94 pads
Standard Error 0.162
|
-1.09 pads
Standard Error 0.176
|
-1.24 pads
Standard Error 0.159
|
-1.30 pads
Standard Error 0.161
|
-1.35 pads
Standard Error 0.189
|
-1.36 pads
Standard Error 0.231
|
|
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30
|
-0.97 pads
Standard Error 0.226
|
-0.90 pads
Standard Error 0.223
|
-1.11 pads
Standard Error 0.213
|
-1.47 pads
Standard Error 0.223
|
-1.25 pads
Standard Error 0.144
|
-1.53 pads
Standard Error 0.253
|
-1.10 pads
Standard Error 0.156
|
-1.39 pads
Standard Error 0.172
|
-1.29 pads
Standard Error 0.155
|
-1.51 pads
Standard Error 0.159
|
-1.37 pads
Standard Error 0.185
|
-1.56 pads
Standard Error 0.227
|
|
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31
|
-0.92 pads
Standard Error 0.246
|
-0.97 pads
Standard Error 0.242
|
-0.93 pads
Standard Error 0.231
|
-1.35 pads
Standard Error 0.251
|
-1.39 pads
Standard Error 0.159
|
-1.75 pads
Standard Error 0.282
|
-1.02 pads
Standard Error 0.174
|
-1.44 pads
Standard Error 0.187
|
-1.45 pads
Standard Error 0.170
|
-1.63 pads
Standard Error 0.172
|
-1.60 pads
Standard Error 0.201
|
-1.60 pads
Standard Error 0.243
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by "n"). LOCF was used for the End of Treatment (EOT) analysis.
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73
|
-0.33 nocturia episodes
Standard Error 0.115
|
-0.37 nocturia episodes
Standard Error 0.123
|
-0.60 nocturia episodes
Standard Error 0.118
|
-0.38 nocturia episodes
Standard Error 0.120
|
-0.30 nocturia episodes
Standard Error 0.085
|
-0.45 nocturia episodes
Standard Error 0.121
|
-0.43 nocturia episodes
Standard Error 0.086
|
-0.51 nocturia episodes
Standard Error 0.087
|
-0.49 nocturia episodes
Standard Error 0.088
|
-0.61 nocturia episodes
Standard Error 0.087
|
-0.43 nocturia episodes
Standard Error 0.119
|
-0.53 nocturia episodes
Standard Error 0.119
|
|
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71
|
-0.50 nocturia episodes
Standard Error 0.116
|
-0.60 nocturia episodes
Standard Error 0.123
|
-0.71 nocturia episodes
Standard Error 0.118
|
-0.55 nocturia episodes
Standard Error 0.118
|
-0.47 nocturia episodes
Standard Error 0.085
|
-0.74 nocturia episodes
Standard Error 0.121
|
-0.59 nocturia episodes
Standard Error 0.087
|
-0.54 nocturia episodes
Standard Error 0.088
|
-0.69 nocturia episodes
Standard Error 0.088
|
-0.80 nocturia episodes
Standard Error 0.086
|
-0.67 nocturia episodes
Standard Error 0.119
|
-0.75 nocturia episodes
Standard Error 0.121
|
|
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70
|
-0.64 nocturia episodes
Standard Error 0.126
|
-0.65 nocturia episodes
Standard Error 0.133
|
-0.68 nocturia episodes
Standard Error 0.127
|
-0.80 nocturia episodes
Standard Error 0.127
|
-0.65 nocturia episodes
Standard Error 0.091
|
-1.01 nocturia episodes
Standard Error 0.128
|
-0.76 nocturia episodes
Standard Error 0.092
|
-0.79 nocturia episodes
Standard Error 0.094
|
-0.76 nocturia episodes
Standard Error 0.095
|
-0.98 nocturia episodes
Standard Error 0.091
|
-0.81 nocturia episodes
Standard Error 0.127
|
-0.91 nocturia episodes
Standard Error 0.130
|
|
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69
|
-0.79 nocturia episodes
Standard Error 0.146
|
-0.69 nocturia episodes
Standard Error 0.154
|
-0.84 nocturia episodes
Standard Error 0.146
|
-0.59 nocturia episodes
Standard Error 0.148
|
-0.70 nocturia episodes
Standard Error 0.106
|
-0.99 nocturia episodes
Standard Error 0.148
|
-0.75 nocturia episodes
Standard Error 0.108
|
-0.81 nocturia episodes
Standard Error 0.109
|
-0.80 nocturia episodes
Standard Error 0.110
|
-1.05 nocturia episodes
Standard Error 0.105
|
-0.98 nocturia episodes
Standard Error 0.147
|
-1.03 nocturia episodes
Standard Error 0.150
|
|
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
EOT; n=78,73,76,75,146,74,143,140,137,147,75,76
|
-0.74 nocturia episodes
Standard Error 0.140
|
-0.69 nocturia episodes
Standard Error 0.145
|
-0.82 nocturia episodes
Standard Error 0.142
|
-0.68 nocturia episodes
Standard Error 0.143
|
-0.69 nocturia episodes
Standard Error 0.102
|
-0.95 nocturia episodes
Standard Error 0.144
|
-0.73 nocturia episodes
Standard Error 0.104
|
-0.77 nocturia episodes
Standard Error 0.105
|
-0.77 nocturia episodes
Standard Error 0.106
|
-1.04 nocturia episodes
Standard Error 0.102
|
-0.94 nocturia episodes
Standard Error 0.143
|
-0.96 nocturia episodes
Standard Error 0.142
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=73 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=75 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=147 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=73 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=143 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=136 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=76 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
|
-1.4 units on a scale
Standard Error 0.14
|
-1.4 units on a scale
Standard Error 0.14
|
-1.5 units on a scale
Standard Error 0.14
|
-1.5 units on a scale
Standard Error 0.14
|
-1.3 units on a scale
Standard Error 0.10
|
-1.5 units on a scale
Standard Error 0.14
|
-1.4 units on a scale
Standard Error 0.10
|
-1.7 units on a scale
Standard Error 0.10
|
-1.7 units on a scale
Standard Error 0.10
|
-1.8 units on a scale
Standard Error 0.10
|
-1.8 units on a scale
Standard Error 0.14
|
-1.6 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=73 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=75 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=147 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=73 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=143 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=136 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=76 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement in PPBC
|
69.2 percentage of participants
|
76.7 percentage of participants
|
78.9 percentage of participants
|
68.0 percentage of participants
|
72.8 percentage of participants
|
84.9 percentage of participants
|
74.5 percentage of participants
|
83.2 percentage of participants
|
77.9 percentage of participants
|
82.6 percentage of participants
|
82.9 percentage of participants
|
75.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=73 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=75 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=147 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=73 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=143 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=136 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=76 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Major Improvement in PPBC
|
39.7 percentage of participants
|
42.5 percentage of participants
|
38.2 percentage of participants
|
44.0 percentage of participants
|
42.2 percentage of participants
|
46.6 percentage of participants
|
48.2 percentage of participants
|
52.4 percentage of participants
|
54.4 percentage of participants
|
54.9 percentage of participants
|
57.9 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=73 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=75 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=147 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=73 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=143 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=136 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=76 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Deterioration in PPBC
|
6.4 percentage of participants
|
4.1 percentage of participants
|
5.3 percentage of participants
|
4.0 percentage of participants
|
4.8 percentage of participants
|
2.7 percentage of participants
|
4.3 percentage of participants
|
2.8 percentage of participants
|
2.9 percentage of participants
|
1.4 percentage of participants
|
1.3 percentage of participants
|
6.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=75 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=75 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=145 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=139 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=146 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
|
-25.5 units on a scale
Standard Error 1.96
|
-27.1 units on a scale
Standard Error 2.01
|
-27.5 units on a scale
Standard Error 2.00
|
-29.8 units on a scale
Standard Error 1.99
|
-26.8 units on a scale
Standard Error 1.42
|
-29.9 units on a scale
Standard Error 2.01
|
-28.0 units on a scale
Standard Error 1.45
|
-31.7 units on a scale
Standard Error 1.45
|
-32.0 units on a scale
Standard Error 1.48
|
-33.5 units on a scale
Standard Error 1.44
|
-33.6 units on a scale
Standard Error 1.97
|
-31.4 units on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=75 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=75 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=145 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=139 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=146 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Symptom Bother Response
|
73.4 percentage of participants
|
84.0 percentage of participants
|
78.9 percentage of participants
|
85.7 percentage of participants
|
81.3 percentage of participants
|
85.3 percentage of participants
|
82.6 percentage of participants
|
85.5 percentage of participants
|
85.6 percentage of participants
|
88.4 percentage of participants
|
88.5 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=75 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=75 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=145 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=139 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=146 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
|
24.5 units on a scale
Standard Error 2.03
|
22.5 units on a scale
Standard Error 2.08
|
25.8 units on a scale
Standard Error 2.07
|
27.7 units on a scale
Standard Error 2.05
|
23.7 units on a scale
Standard Error 1.47
|
26.6 units on a scale
Standard Error 2.08
|
25.5 units on a scale
Standard Error 1.50
|
28.5 units on a scale
Standard Error 1.50
|
29.2 units on a scale
Standard Error 1.53
|
30.1 units on a scale
Standard Error 1.49
|
30.3 units on a scale
Standard Error 2.04
|
28.9 units on a scale
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=75 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=75 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=145 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=139 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=146 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Health-related Quality of Life Total Score Response
|
67.1 percentage of participants
|
57.3 percentage of participants
|
71.1 percentage of participants
|
74.0 percentage of participants
|
72.7 percentage of participants
|
74.7 percentage of participants
|
72.9 percentage of participants
|
78.6 percentage of participants
|
77.0 percentage of participants
|
84.2 percentage of participants
|
79.5 percentage of participants
|
82.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Missing data → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Missing data → Confined to bed
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
No problem → Confined to bed
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
No problem → No problem
|
60 participants
|
58 participants
|
63 participants
|
59 participants
|
118 participants
|
54 participants
|
94 participants
|
113 participants
|
102 participants
|
120 participants
|
59 participants
|
56 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
No problem → Some problems
|
6 participants
|
1 participants
|
4 participants
|
4 participants
|
6 participants
|
4 participants
|
9 participants
|
5 participants
|
9 participants
|
1 participants
|
0 participants
|
5 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
No problem → Missing data
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Confined → Confined to bed
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Some problems → No problems
|
5 participants
|
6 participants
|
6 participants
|
4 participants
|
11 participants
|
8 participants
|
21 participants
|
15 participants
|
13 participants
|
14 participants
|
11 participants
|
8 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Some problems → Some problems
|
8 participants
|
10 participants
|
3 participants
|
10 participants
|
15 participants
|
9 participants
|
20 participants
|
12 participants
|
15 participants
|
11 participants
|
8 participants
|
9 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Some problems → Confined to bed
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Some problems → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Confined → No problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Confined → Some problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Confined → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Missing data → No problem
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Missing data → Some problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
No problem → No problem
|
76 participants
|
69 participants
|
73 participants
|
72 participants
|
138 participants
|
68 participants
|
128 participants
|
138 participants
|
130 participants
|
141 participants
|
74 participants
|
72 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
No problem → Some problems
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
2 participants
|
2 participants
|
5 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
No problem → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
No problem → Missing data
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Some problems → No problems
|
1 participants
|
4 participants
|
0 participants
|
1 participants
|
6 participants
|
3 participants
|
8 participants
|
3 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Some problems → Some problems
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
2 participants
|
4 participants
|
2 participants
|
2 participants
|
4 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Some problems → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Some problems → Missing data
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Unable → No problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Unable → Some problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Unable → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Unable → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Missing data → No problem
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Missing data → Some problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Missing data → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Missing data → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
No problem → No problem
|
62 participants
|
52 participants
|
58 participants
|
60 participants
|
115 participants
|
57 participants
|
89 participants
|
110 participants
|
106 participants
|
109 participants
|
57 participants
|
48 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Missing data → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
No problem → Some problems
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
3 participants
|
4 participants
|
8 participants
|
3 participants
|
9 participants
|
4 participants
|
1 participants
|
5 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
No problem → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
No problem → Missing data
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Some problems → No problems
|
11 participants
|
11 participants
|
8 participants
|
11 participants
|
16 participants
|
7 participants
|
29 participants
|
24 participants
|
12 participants
|
21 participants
|
14 participants
|
14 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Some problems → Some problems
|
4 participants
|
10 participants
|
6 participants
|
4 participants
|
13 participants
|
6 participants
|
18 participants
|
8 participants
|
11 participants
|
12 participants
|
4 participants
|
8 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Some problems → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Some problems → Missing data
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Unable → No problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Unable → Some problems
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Unable → Unable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Unable → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Missing data → No problem
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Missing data → Some problems
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Missing data → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Missing data → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
No pain → No pain
|
38 participants
|
33 participants
|
40 participants
|
38 participants
|
70 participants
|
35 participants
|
67 participants
|
61 participants
|
66 participants
|
73 participants
|
39 participants
|
32 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
No pain → Moderate pain
|
9 participants
|
12 participants
|
6 participants
|
4 participants
|
15 participants
|
3 participants
|
6 participants
|
11 participants
|
14 participants
|
7 participants
|
8 participants
|
6 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
No pain → Extreme pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
No pain → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Moderate pain → No pain
|
12 participants
|
14 participants
|
10 participants
|
12 participants
|
24 participants
|
13 participants
|
24 participants
|
34 participants
|
28 participants
|
36 participants
|
14 participants
|
20 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Moderate pain → Moderate pain
|
16 participants
|
15 participants
|
19 participants
|
19 participants
|
37 participants
|
18 participants
|
37 participants
|
33 participants
|
27 participants
|
25 participants
|
12 participants
|
18 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Moderate pain → Extreme pain
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Moderate pain → Missing data
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Extreme pain → No pain
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Extreme pain → Moderate pain
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
4 participants
|
3 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Extreme pain → Extreme pain
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Extreme pain → Missing data
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Missing data → No pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Missing data → Moderate pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Missing data → Extreme pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
No anxiety → No anxiety
|
41 participants
|
38 participants
|
39 participants
|
42 participants
|
76 participants
|
36 participants
|
81 participants
|
78 participants
|
76 participants
|
80 participants
|
44 participants
|
36 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
No anxiety → Moderate anxiety
|
5 participants
|
8 participants
|
7 participants
|
4 participants
|
11 participants
|
6 participants
|
7 participants
|
5 participants
|
9 participants
|
3 participants
|
5 participants
|
6 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
No anxiety → Extreme anxiety
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
No anxiety → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Moderate anxiety → No anxiety
|
17 participants
|
9 participants
|
15 participants
|
21 participants
|
24 participants
|
19 participants
|
25 participants
|
35 participants
|
28 participants
|
33 participants
|
15 participants
|
14 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Moderate anxiety → Moderate anxiety
|
13 participants
|
18 participants
|
14 participants
|
9 participants
|
33 participants
|
12 participants
|
21 participants
|
22 participants
|
19 participants
|
26 participants
|
8 participants
|
19 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Moderate anxiety → Extreme anxiety
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Moderate anxiety → Missing data
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Extreme anxiety → No anxiety
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Extreme anxiety → Moderate anxiety
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
7 participants
|
1 participants
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Extreme anxiety → Extreme anxiety
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Extreme anxiety → Missing data
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Missing data → No anxiety
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Missing data → Moderate anxiety
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Missing data → Extreme anxiety
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Missing data → Missing data
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=75 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=75 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=144 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=145 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=139 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=146 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
|
13.1 units on a scale
Standard Deviation 21.11
|
5.8 units on a scale
Standard Deviation 19.38
|
14.3 units on a scale
Standard Deviation 22.38
|
11.1 units on a scale
Standard Deviation 19.26
|
11.9 units on a scale
Standard Deviation 21.33
|
13.3 units on a scale
Standard Deviation 21.81
|
11.6 units on a scale
Standard Deviation 21.94
|
12.5 units on a scale
Standard Deviation 19.95
|
11.8 units on a scale
Standard Deviation 18.91
|
15.9 units on a scale
Standard Deviation 20.94
|
15.3 units on a scale
Standard Deviation 24.17
|
11.1 units on a scale
Standard Deviation 23.18
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=76 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=77 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=77 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=150 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=76 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=146 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=147 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=150 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=80 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
Percent work time missed
|
-2.44 units on a scale
Standard Deviation 10.580
|
0.53 units on a scale
Standard Deviation 3.031
|
-0.24 units on a scale
Standard Deviation 1.988
|
-2.85 units on a scale
Standard Deviation 11.205
|
-1.29 units on a scale
Standard Deviation 12.606
|
-0.28 units on a scale
Standard Deviation 2.737
|
-0.55 units on a scale
Standard Deviation 12.816
|
-0.83 units on a scale
Standard Deviation 17.199
|
-0.84 units on a scale
Standard Deviation 5.330
|
-1.65 units on a scale
Standard Deviation 4.654
|
0.79 units on a scale
Standard Deviation 6.757
|
-1.12 units on a scale
Standard Deviation 11.025
|
|
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
Percent impairment while working
|
-7.50 units on a scale
Standard Deviation 24.539
|
-16.13 units on a scale
Standard Deviation 24.314
|
-10.00 units on a scale
Standard Deviation 22.220
|
-16.67 units on a scale
Standard Deviation 25.207
|
-17.33 units on a scale
Standard Deviation 22.689
|
-10.00 units on a scale
Standard Deviation 17.728
|
-8.43 units on a scale
Standard Deviation 27.523
|
-17.72 units on a scale
Standard Deviation 26.187
|
-13.85 units on a scale
Standard Deviation 27.664
|
-13.39 units on a scale
Standard Deviation 24.515
|
-18.00 units on a scale
Standard Deviation 29.642
|
-9.29 units on a scale
Standard Deviation 26.377
|
|
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
Percent overall work impairment
|
-9.50 units on a scale
Standard Deviation 24.090
|
-16.32 units on a scale
Standard Deviation 24.653
|
-9.91 units on a scale
Standard Deviation 21.464
|
-17.88 units on a scale
Standard Deviation 28.134
|
-17.26 units on a scale
Standard Deviation 25.196
|
-9.95 units on a scale
Standard Deviation 17.988
|
-8.59 units on a scale
Standard Deviation 29.521
|
-17.16 units on a scale
Standard Deviation 27.695
|
-14.00 units on a scale
Standard Deviation 27.384
|
-14.18 units on a scale
Standard Deviation 25.092
|
-17.69 units on a scale
Standard Deviation 29.323
|
-10.32 units on a scale
Standard Deviation 27.580
|
|
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
Percent activity impairment
|
-9.62 units on a scale
Standard Deviation 26.989
|
-14.52 units on a scale
Standard Deviation 27.439
|
-13.95 units on a scale
Standard Deviation 26.386
|
-13.73 units on a scale
Standard Deviation 27.052
|
-14.38 units on a scale
Standard Deviation 24.182
|
-17.12 units on a scale
Standard Deviation 27.813
|
-14.11 units on a scale
Standard Deviation 31.398
|
-25.31 units on a scale
Standard Deviation 26.158
|
-17.43 units on a scale
Standard Deviation 29.008
|
-20.42 units on a scale
Standard Deviation 27.094
|
-19.34 units on a scale
Standard Deviation 27.439
|
-19.74 units on a scale
Standard Deviation 30.021
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=73 Participants
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=76 Participants
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=75 Participants
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=147 Participants
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=73 Participants
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 25 mg
n=141 Participants
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg + Mirabegron 50 mg
n=143 Participants
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 25 mg
n=136 Participants
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg + Mirabegron 50 mg
n=144 Participants
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 25 mg
n=76 Participants
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg + Mirabegron 50 mg
n=78 Participants
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
|
2.44 units on a scale
Standard Error 0.298
|
2.61 units on a scale
Standard Error 0.307
|
3.17 units on a scale
Standard Error 0.301
|
3.10 units on a scale
Standard Error 0.303
|
2.78 units on a scale
Standard Error 0.217
|
2.96 units on a scale
Standard Error 0.307
|
2.96 units on a scale
Standard Error 0.221
|
3.24 units on a scale
Standard Error 0.220
|
3.47 units on a scale
Standard Error 0.225
|
3.24 units on a scale
Standard Error 0.219
|
3.51 units on a scale
Standard Error 0.301
|
3.72 units on a scale
Standard Error 0.297
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Mirabegron 25 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Mirabegron 50 mg
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Solifenacin 2.5 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Solifenacin 5 mg
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Solifenacin 10 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Solifenacin 2.5 mg and Mirabegron 25 mg
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Solifenacin 2.5 mg and Mirabegron 50 mg
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Solifenacin 5 mg and Mirabegron 25 mg
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Solifenacin 5 mg and Mirabegron 50 mg
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Solifenacin 10 mg and Mirabegron 25 mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Solifenacin 10 mg and Mirabegron 50 mg
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=77 participants at risk
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=78 participants at risk
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=79 participants at risk
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=156 participants at risk
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=78 participants at risk
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg and Mirabegron 25 mg
n=149 participants at risk
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg and Mirabegron 50 mg
n=149 participants at risk
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg and Mirabegron 25 mg
n=144 participants at risk
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg and Mirabegron 50 mg
n=153 participants at risk
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg and Mirabegron 25 mg
n=81 participants at risk
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg and Mirabegron 50 mg
n=81 participants at risk
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.69%
1/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.65%
1/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.69%
1/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.65%
1/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.69%
1/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.65%
1/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
General disorders
Fibrosis
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.65%
1/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.2%
1/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.2%
1/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Participants received matching placebo tablets orally once a day for 12 weeks.
|
Mirabegron 25 mg
n=77 participants at risk
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Mirabegron 50 mg
n=78 participants at risk
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg
n=79 participants at risk
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg
n=156 participants at risk
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg
n=78 participants at risk
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg and Mirabegron 25 mg
n=149 participants at risk
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 2.5 mg and Mirabegron 50 mg
n=149 participants at risk
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg and Mirabegron 25 mg
n=144 participants at risk
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 5 mg and Mirabegron 50 mg
n=153 participants at risk
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg and Mirabegron 25 mg
n=81 participants at risk
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
|
Solifenacin 10 mg and Mirabegron 50 mg
n=81 participants at risk
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
3/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
2/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
5.1%
4/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.6%
6/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
11.5%
18/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
29.5%
23/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
12.8%
19/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
8.7%
13/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
14.6%
21/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
13.1%
20/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
19.8%
16/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
17.3%
14/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.8%
3/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.9%
3/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
5.1%
4/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
4.7%
7/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
4.0%
6/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.8%
4/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
2/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.4%
6/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
9.9%
8/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
2/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.5%
5/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.4%
5/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.3%
5/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.8%
6/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
2/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.7%
4/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
4.0%
6/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
4.9%
7/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.9%
6/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.4%
6/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.4%
6/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Infections and infestations
Escherichia urinary tract infection
|
2.5%
2/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
2/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.8%
6/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.4%
5/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.0%
3/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
2/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.1%
3/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
4/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.7%
3/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.2%
1/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
3/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
2/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
1/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.6%
4/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.4%
5/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.67%
1/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.3%
2/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
1.4%
2/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
2.0%
3/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
0.00%
0/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
3.7%
3/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
|
Vascular disorders
Hypertension
|
8.6%
7/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
11.7%
9/77 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
14.1%
11/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
10.1%
8/79 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
11.5%
18/156 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
6.4%
5/78 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.4%
11/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.4%
11/149 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
7.6%
11/144 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
5.9%
9/153 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
8.6%
7/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
13.6%
11/81 • Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
The SAF included all patients randomized to a double-blind treatment who took at least 1 dose of study drug.One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 90 days prior to publication for review and comment.
- Publication restrictions are in place
Restriction type: OTHER