Trial Outcomes & Findings for A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) (NCT NCT02138747)
NCT ID: NCT02138747
Last Updated: 2020-02-26
Results Overview
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
376 participants
Primary outcome timeframe
Week 8 (End of Period 1) and Week 18 (End of Period 2)
Results posted on
2020-02-26
Participant Flow
Recruited participants were male and female over 18 years of age with overactive bladder (OAB) symptoms and naïve to pharmacologic treatment. The study was conducted at 36 sites (8 sites in Canada and 28 sites in the US).
After screening, participants were randomized into 1 of 4 sequences in a 5:5:1:1 ratio (mirabegron/tolterodine extended release (ER), tolterodine ER/mirabegron, mirabegron/mirabegron or tolterodine ER/tolterodine ER. Each participant completed 2 double-blind treatment periods with a 2-week washout period between the two periods.
Participant milestones
| Measure |
AB: Mirabegron/Tolterodine ER
In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
BA: Tolterodine ER /Mirabegron
In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
156
|
157
|
31
|
32
|
|
Treatment Period 1
COMPLETED
|
136
|
132
|
27
|
28
|
|
Treatment Period 1
NOT COMPLETED
|
20
|
25
|
4
|
4
|
|
Treatment Period 2
STARTED
|
138
|
132
|
26
|
27
|
|
Treatment Period 2
COMPLETED
|
121
|
125
|
24
|
24
|
|
Treatment Period 2
NOT COMPLETED
|
17
|
7
|
2
|
3
|
Reasons for withdrawal
| Measure |
AB: Mirabegron/Tolterodine ER
In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
BA: Tolterodine ER /Mirabegron
In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
10
|
14
|
2
|
1
|
|
Treatment Period 1
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
2
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
8
|
4
|
1
|
3
|
|
Treatment Period 1
Other - Miscellaneous
|
2
|
4
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
6
|
3
|
1
|
1
|
|
Treatment Period 2
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Treatment Period 2
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
5
|
4
|
1
|
2
|
|
Treatment Period 2
Other - Miscellaneous
|
3
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
Baseline characteristics by cohort
| Measure |
AB: Mirabegron/Tolterodine ER
n=156 Participants
In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
BA: Tolterodine ER /Mirabegron
n=157 Participants
In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
|
AA: Mirabegron/Mirabegron
n=31 Participants
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
n=32 Participants
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 14.68 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 12.65 • n=7 Participants
|
59.3 Years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
55.1 Years
STANDARD_DEVIATION 14.30 • n=4 Participants
|
53.7 Years
STANDARD_DEVIATION 13.75 • n=21 Participants
|
|
Age, Customized
< 65 Years
|
119 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
291 Participants
n=21 Participants
|
|
Age, Customized
>= 65 Years
|
37 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
277 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Mean Number of Incontinence Episodes per 24 Hours
|
3.11 Incontinence Episodes/24 Hours
STANDARD_DEVIATION 4.2 • n=5 Participants
|
3.29 Incontinence Episodes/24 Hours
STANDARD_DEVIATION 4.6 • n=7 Participants
|
3.76 Incontinence Episodes/24 Hours
STANDARD_DEVIATION 5.17 • n=5 Participants
|
3.73 Incontinence Episodes/24 Hours
STANDARD_DEVIATION 4.92 • n=4 Participants
|
3.29 Incontinence Episodes/24 Hours
STANDARD_DEVIATION 4.51 • n=21 Participants
|
|
Mean Number of Urgency Incontinence Episodes per 24 Hours
|
2.82 Urgency Incontinence Episodes
STANDARD_DEVIATION 4.18 • n=5 Participants
|
2.83 Urgency Incontinence Episodes
STANDARD_DEVIATION 4.25 • n=7 Participants
|
3.68 Urgency Incontinence Episodes
STANDARD_DEVIATION 5.19 • n=5 Participants
|
3.54 Urgency Incontinence Episodes
STANDARD_DEVIATION 4.83 • n=4 Participants
|
2.96 Urgency Incontinence Episodes
STANDARD_DEVIATION 4.35 • n=21 Participants
|
|
Mean Number of Micturitions per 24 Hours
|
11.24 Micturitions
STANDARD_DEVIATION 2.62 • n=5 Participants
|
11.65 Micturitions
STANDARD_DEVIATION 3.68 • n=7 Participants
|
12.76 Micturitions
STANDARD_DEVIATION 2.63 • n=5 Participants
|
11.85 Micturitions
STANDARD_DEVIATION 2.57 • n=4 Participants
|
11.59 Micturitions
STANDARD_DEVIATION 3.12 • n=21 Participants
|
|
Mean Number of Urgency Episodes per 24 Hours
|
5.3 Urgency Episodes
STANDARD_DEVIATION 4.1 • n=5 Participants
|
5.61 Urgency Episodes
STANDARD_DEVIATION 4.61 • n=7 Participants
|
6.23 Urgency Episodes
STANDARD_DEVIATION 4.47 • n=5 Participants
|
6.29 Urgency Episodes
STANDARD_DEVIATION 4.55 • n=4 Participants
|
5.59 Urgency Episodes
STANDARD_DEVIATION 4.38 • n=21 Participants
|
|
Mean Number of Nocturia Episodes per 24 Hours
|
1.63 Nocturia Episodes
STANDARD_DEVIATION 1.03 • n=5 Participants
|
1.49 Nocturia Episodes
STANDARD_DEVIATION 0.95 • n=7 Participants
|
2.23 Nocturia Episodes
STANDARD_DEVIATION 1.05 • n=5 Participants
|
1.58 Nocturia Episodes
STANDARD_DEVIATION 1.17 • n=4 Participants
|
1.62 Nocturia Episodes
STANDARD_DEVIATION 1.03 • n=21 Participants
|
|
Duration of OAB Symptoms (Months)
|
82.75 Months
STANDARD_DEVIATION 74.89 • n=5 Participants
|
83.92 Months
STANDARD_DEVIATION 104.56 • n=7 Participants
|
73.54 Months
STANDARD_DEVIATION 83.61 • n=5 Participants
|
67.54 Months
STANDARD_DEVIATION 58.21 • n=4 Participants
|
81.19 Months
STANDARD_DEVIATION 87.92 • n=21 Participants
|
|
Incontinence at Baseline of Period 1
Wet
|
117 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
274 Participants
n=21 Participants
|
|
Incontinence at Baseline of Period 1
Dry
|
39 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Type of OAB
Urgency
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Type of OAB
Mixed
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Type of OAB
Frequency urgency without incontinence
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Previous Nondrug Treatment for OAB
Yes
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Previous Nondrug Treatment for OAB
No
|
150 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
360 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).
Outcome measures
| Measure |
Mirabegron
n=341 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=336 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
|
86.29 Units on a Scale
Standard Error 1.418
|
83.40 Units on a Scale
Standard Error 1.423
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 18 (End of Period 2)Population: Full Analysis Set (FAS-PNP \[Preference/No Preference\]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form.
Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug."
Outcome measures
| Measure |
Mirabegron
n=127 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=125 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
n=25 Participants
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
n=26 Participants
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
Preference for Period 1
|
29.9 Percentage of participants
|
34.4 Percentage of participants
|
36.0 Percentage of participants
|
23.1 Percentage of participants
|
|
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
Preference for Period 2
|
37.8 Percentage of participants
|
37.6 Percentage of participants
|
36.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
No Preference
|
32.3 Percentage of participants
|
28.0 Percentage of participants
|
28.0 Percentage of participants
|
26.9 Percentage of participants
|
|
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
Total With Preference
|
67.7 Percentage of participants
|
72.0 Percentage of participants
|
72.0 Percentage of participants
|
73.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.
Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
|
72.98 Units on a Scale
Standard Error 1.419
|
71.92 Units on a Scale
Standard Error 1.521
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
OAB control was scored from 0 to 100, with higher scores indicating better OAB control.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
|
64.49 Units on a Scale
Standard Error 1.205
|
63.38 Units on a Scale
Standard Error 1.266
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
|
69.17 Units on a Scale
Standard Error 1.491
|
68.31 Units on a Scale
Standard Error 1.524
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
|
3.10 Units on a Scale
Standard Error 0.072
|
3.08 Units on a Scale
Standard Error 0.073
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
|
3.00 Unit on a Scale
Standard Error 0.068
|
3.02 Unit on a Scale
Standard Error 0.067
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
|
3.70 Units on a Scale
Standard Error 0.071
|
3.66 Units on a Scale
Standard Error 0.074
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
|
3.69 Units on a Scale
Standard Error 0.071
|
3.69 Units on a Scale
Standard Error 0.071
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)Population: Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.
Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.
Outcome measures
| Measure |
Mirabegron
n=336 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=330 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
|
3.43 Units on a Scale
Standard Error 0.079
|
3.46 Units on a Scale
Standard Error 0.078
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)Population: Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized.
Outcome measures
| Measure |
Mirabegron
n=243 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=233 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
|
-1.51 Incontinence Episodes
Standard Error 0.194
|
-1.46 Incontinence Episodes
Standard Error 0.194
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)Population: Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.
Outcome measures
| Measure |
Mirabegron
n=331 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=327 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
|
-2.06 Micturitions
Standard Error 0.194
|
-1.95 Micturitions
Standard Error 0.195
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to EOT (Week 18) and follow up (Week 20)Population: Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF).
Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests \[LFTs\]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.
Outcome measures
| Measure |
Mirabegron
n=319 Participants
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=325 Participants
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
AEs Leading to Permanent Discontinuation of Drug
|
15 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Drug-related SAEs Leading to Permanent Discontinu
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Adverse Events (AEs)
|
150 Participants
|
168 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Drug-related (AEs)
|
89 Participants
|
111 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Serious Adverse Event (SAE)
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Drug-related SAEs
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Drug-related AEs Leading to Permanent Discontinuat
|
12 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
SAEs Leading to Permanent Discontinuation
|
0 Participants
|
5 Participants
|
—
|
—
|
Adverse Events
Mirabegron
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
Tolterodine ER
Serious events: 8 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirabegron
n=319 participants at risk
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=325 participants at risk
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
2/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.62%
2/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.00%
0/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
0.31%
1/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
Other adverse events
| Measure |
Mirabegron
n=319 participants at risk
Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
|
Tolterodine ER
n=325 participants at risk
Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
29/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
16.3%
53/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
18/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
6.2%
20/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
|
Nervous system disorders
Headache
|
5.6%
18/319 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
5.8%
19/325 • Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
|
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 primary publication of the multi-site data. Sponsor must receive a site's manuscript at least 45 days prior to planned submission to ensure that no confidential information of Sponsor is included in the document. In addition if requested by sponsor any publication or presentation shall be delayed for a period not to exceed 60 days.
- Publication restrictions are in place
Restriction type: OTHER