Trial Outcomes & Findings for A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (NCT NCT01565707)

Last Updated: 2024-10-31

Results Overview

The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

189 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-10-31

Participant Flow

The study population consisted of male and female children (5 to 11 years old) and adolescents (12 to 17 years old) with overactive bladder (OAB).

Subjects received 4 weeks of urotherapy (standard first line therapy for pediatric OAB patients). Two weeks after start of urotherapy a single-blind 2-week placebo run-in period began. After run-in period eligible subjects were randomized to 12 weeks of double-blind treatment (solifenacin succinate suspension or placebo) and continued urotherapy.

Participant milestones

Participant milestones
Measure	Placebo Children Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Children Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.	Placebo Adolescents Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Adolescents Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Overall Study STARTED	75	73	19	22
Overall Study Treated	73	73	19	22
Overall Study COMPLETED	66	65	16	17
Overall Study NOT COMPLETED	9	8	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Children Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Children Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.	Placebo Adolescents Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Adolescents Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Overall Study Adverse Event	1	6	2	1
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Protocol Violation	1	0	0	1
Overall Study Withdrawal by Subject	3	1	1	1
Overall Study Randomized but not evaluable	2	0	0	0
Overall Study Miscellaneous	1	1	0	2

Baseline Characteristics

A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Children n=73 Participants Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Children n=73 Participants Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.	Placebo Adolescents n=19 Participants Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Adolescents n=22 Participants Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.	Total n=187 Participants Total of all reporting groups
Age, Continuous Children	7.4 years STANDARD_DEVIATION 1.6 • n=5 Participants	7.6 years STANDARD_DEVIATION 1.6 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	7.5 years STANDARD_DEVIATION 1.6 • n=21 Participants
Age, Continuous Adolescents	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	14.4 years STANDARD_DEVIATION 1.9 • n=5 Participants	14.2 years STANDARD_DEVIATION 1.8 • n=4 Participants	14.3 years STANDARD_DEVIATION 1.8 • n=21 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	44 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	112 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	29 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	75 Participants n=21 Participants
Race White	57 Participants n=5 Participants	62 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	148 Participants n=21 Participants
Race Black/African American	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Race American Indian/Alaskan Native	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Race Other	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity Not Hispanic or Latino	65 Participants n=5 Participants	64 Participants n=7 Participants	16 Participants n=5 Participants	20 Participants n=4 Participants	165 Participants n=21 Participants
Mean Volume Voided (MVV) per Micturition Children	94.06 mL STANDARD_DEVIATION 38.12 • n=5 Participants	96.88 mL STANDARD_DEVIATION 40.98 • n=7 Participants	NA mL STANDARD_DEVIATION NA • n=5 Participants	NA mL STANDARD_DEVIATION NA • n=4 Participants	95.50 mL STANDARD_DEVIATION 39.50 • n=21 Participants
Mean Volume Voided (MVV) per Micturition Adolescents	NA mL STANDARD_DEVIATION NA • n=5 Participants	NA mL STANDARD_DEVIATION NA • n=7 Participants	169.06 mL STANDARD_DEVIATION 63.65 • n=5 Participants	159.55 mL STANDARD_DEVIATION 61.21 • n=4 Participants	164.07 mL STANDARD_DEVIATION 61.76 • n=21 Participants
Daytime Maximum Volume Voided (DMaxVV) Per Micturition Children	141.43 mL STANDARD_DEVIATION 52.09 • n=5 Participants	155.51 mL STANDARD_DEVIATION 70.66 • n=7 Participants	NA mL STANDARD_DEVIATION NA • n=5 Participants	NA mL STANDARD_DEVIATION NA • n=4 Participants	148.62 mL STANDARD_DEVIATION 62.45 • n=21 Participants
Daytime Maximum Volume Voided (DMaxVV) Per Micturition Adolescents	NA mL STANDARD_DEVIATION NA • n=5 Participants	NA mL STANDARD_DEVIATION NA • n=7 Participants	278.16 mL STANDARD_DEVIATION 119.21 • n=5 Participants	252.38 mL STANDARD_DEVIATION 108.68 • n=4 Participants	264.63 mL STANDARD_DEVIATION 113.08 • n=21 Participants
Mean Number of Incontinence Episodes per 24 Hours Children	2.98 incontinence episodes STANDARD_DEVIATION 2.63 • n=5 Participants	2.46 incontinence episodes STANDARD_DEVIATION 2.57 • n=7 Participants	NA incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA incontinence episodes STANDARD_DEVIATION NA • n=4 Participants	2.71 incontinence episodes STANDARD_DEVIATION 2.60 • n=21 Participants
Mean Number of Incontinence Episodes per 24 Hours Adolescents	NA incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA incontinence episodes STANDARD_DEVIATION NA • n=7 Participants	2.81 incontinence episodes STANDARD_DEVIATION 2.45 • n=5 Participants	1.82 incontinence episodes STANDARD_DEVIATION 1.66 • n=4 Participants	2.29 incontinence episodes STANDARD_DEVIATION 2.11 • n=21 Participants
Mean Number of Daytime Incontinence Episodes per 24 Hours Children	2.54 daytime incontinence episodes STANDARD_DEVIATION 2.75 • n=5 Participants	1.98 daytime incontinence episodes STANDARD_DEVIATION 3.24 • n=7 Participants	NA daytime incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA daytime incontinence episodes STANDARD_DEVIATION NA • n=4 Participants	2.26 daytime incontinence episodes STANDARD_DEVIATION 3.01 • n=21 Participants
Mean Number of Daytime Incontinence Episodes per 24 Hours Adolescents	NA daytime incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA daytime incontinence episodes STANDARD_DEVIATION NA • n=7 Participants	2.03 daytime incontinence episodes STANDARD_DEVIATION 2.18 • n=5 Participants	1.50 daytime incontinence episodes STANDARD_DEVIATION 1.44 • n=4 Participants	1.75 daytime incontinence episodes STANDARD_DEVIATION 1.83 • n=21 Participants
Mean Number of Nighttime Incontinence Episodes per 24 Hours Children	0.59 nighttime incontinence episodes STANDARD_DEVIATION 0.47 • n=5 Participants	0.70 nighttime incontinence episodes STANDARD_DEVIATION 0.82 • n=7 Participants	NA nighttime incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA nighttime incontinence episodes STANDARD_DEVIATION NA • n=4 Participants	0.64 nighttime incontinence episodes STANDARD_DEVIATION 0.67 • n=21 Participants
Mean Number of Nighttime Incontinence Episodes per 24 Hours Adolescents	NA nighttime incontinence episodes STANDARD_DEVIATION NA • n=5 Participants	NA nighttime incontinence episodes STANDARD_DEVIATION NA • n=7 Participants	0.39 nighttime incontinence episodes STANDARD_DEVIATION 0.66 • n=5 Participants	0.33 nighttime incontinence episodes STANDARD_DEVIATION 0.40 • n=4 Participants	0.36 nighttime incontinence episodes STANDARD_DEVIATION 0.53 • n=21 Participants
Number of Dry (Incontinence-free) Days per 7 Days Children	0.5 Dry Days STANDARD_DEVIATION 0.9 • n=5 Participants	0.9 Dry Days STANDARD_DEVIATION 1.6 • n=7 Participants	NA Dry Days STANDARD_DEVIATION NA • n=5 Participants	NA Dry Days STANDARD_DEVIATION NA • n=4 Participants	0.7 Dry Days STANDARD_DEVIATION 1.3 • n=21 Participants
Number of Dry (Incontinence-free) Days per 7 Days Adolescents	NA Dry Days STANDARD_DEVIATION NA • n=5 Participants	NA Dry Days STANDARD_DEVIATION NA • n=7 Participants	1.0 Dry Days STANDARD_DEVIATION 1.0 • n=5 Participants	1.5 Dry Days STANDARD_DEVIATION 1.3 • n=4 Participants	1.3 Dry Days STANDARD_DEVIATION 1.2 • n=21 Participants
Number of Dry (Incontinence-free) Nights per 7 Days Children	3.4 Dry Nights STANDARD_DEVIATION 3.0 • n=5 Participants	3.1 Dry Nights STANDARD_DEVIATION 3.0 • n=7 Participants	NA Dry Nights STANDARD_DEVIATION NA • n=5 Participants	NA Dry Nights STANDARD_DEVIATION NA • n=4 Participants	3.2 Dry Nights STANDARD_DEVIATION 3.0 • n=21 Participants
Number of Dry (Incontinence-free) Nights per 7 Days Adolescents	NA Dry Nights STANDARD_DEVIATION NA • n=5 Participants	NA Dry Nights STANDARD_DEVIATION NA • n=7 Participants	5.6 Dry Nights STANDARD_DEVIATION 2.2 • n=5 Participants	5.4 Dry Nights STANDARD_DEVIATION 2.2 • n=4 Participants	5.5 Dry Nights STANDARD_DEVIATION 2.2 • n=21 Participants
Mean Number of Micturitions per 24 Hours Children	8.26 micturitions STANDARD_DEVIATION 2.56 • n=5 Participants	8.27 micturitions STANDARD_DEVIATION 3.01 • n=7 Participants	NA micturitions STANDARD_DEVIATION NA • n=5 Participants	NA micturitions STANDARD_DEVIATION NA • n=4 Participants	8.27 micturitions STANDARD_DEVIATION 2.79 • n=21 Participants
Mean Number of Micturitions per 24 Hours Adolescents	NA micturitions STANDARD_DEVIATION NA • n=5 Participants	NA micturitions STANDARD_DEVIATION NA • n=7 Participants	8.08 micturitions STANDARD_DEVIATION 3.82 • n=5 Participants	7.52 micturitions STANDARD_DEVIATION 2.37 • n=4 Participants	7.79 micturitions STANDARD_DEVIATION 3.11 • n=21 Participants
Mean Number of Daytime Micturitions per 24 Hours Children	7.54 daytime micturitions STANDARD_DEVIATION 3.14 • n=5 Participants	8.00 daytime micturitions STANDARD_DEVIATION 3.40 • n=7 Participants	NA daytime micturitions STANDARD_DEVIATION NA • n=5 Participants	NA daytime micturitions STANDARD_DEVIATION NA • n=4 Participants	7.77 daytime micturitions STANDARD_DEVIATION 3.27 • n=21 Participants
Mean Number of Daytime Micturitions per 24 Hours Adolescents	NA daytime micturitions STANDARD_DEVIATION NA • n=5 Participants	NA daytime micturitions STANDARD_DEVIATION NA • n=7 Participants	6.79 daytime micturitions STANDARD_DEVIATION 2.92 • n=5 Participants	6.88 daytime micturitions STANDARD_DEVIATION 2.14 • n=4 Participants	6.84 daytime micturitions STANDARD_DEVIATION 2.51 • n=21 Participants
Mean Number of Nighttime Micturitions per 24 Hours Children	0.60 nighttime micturitions STANDARD_DEVIATION 0.78 • n=5 Participants	0.56 nighttime micturitions STANDARD_DEVIATION 0.98 • n=7 Participants	NA nighttime micturitions STANDARD_DEVIATION NA • n=5 Participants	NA nighttime micturitions STANDARD_DEVIATION NA • n=4 Participants	0.58 nighttime micturitions STANDARD_DEVIATION 0.88 • n=21 Participants
Mean Number of Nighttime Micturitions per 24 Hours Adolescents	NA nighttime micturitions STANDARD_DEVIATION NA • n=5 Participants	NA nighttime micturitions STANDARD_DEVIATION NA • n=7 Participants	0.61 nighttime micturitions STANDARD_DEVIATION 1.09 • n=5 Participants	0.26 nighttime micturitions STANDARD_DEVIATION 0.41 • n=4 Participants	0.43 nighttime micturitions STANDARD_DEVIATION 0.81 • n=21 Participants
Mean Number of Grade 3 or 4 Urgency Episodes per 24 Hours in Adolescents	NA urgency episodes STANDARD_DEVIATION NA • n=5 Participants	NA urgency episodes STANDARD_DEVIATION NA • n=7 Participants	3.67 urgency episodes STANDARD_DEVIATION 4.15 • n=5 Participants	2.42 urgency episodes STANDARD_DEVIATION 2.13 • n=4 Participants	3.03 urgency episodes STANDARD_DEVIATION 3.29 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition	25.5 mL Standard Error 4.8	6.9 mL Standard Error 14.6	2.3 mL Standard Error 14.0	—	13.4 mL Standard Error 4.8

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition	43.2 mL Standard Error 11.1	-8.4 mL Standard Error 27.0	-25.7 mL Standard Error 26.3	—	11.3 mL Standard Error 11.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	-1.1 incontinence episodes Standard Error 0.2	-0.7 incontinence episodes Standard Error 0.4	-0.6 incontinence episodes Standard Error 0.4	—	-1.2 incontinence episodes Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.

The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=71 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours	-1.2 daytime incontinence episodes Standard Error 0.2	-0.2 daytime incontinence episodes Standard Error 0.4	-0.8 daytime incontinence episodes Standard Error 0.4	—	-1.1 daytime incontinence episodes Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=71 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours	-0.1 nighttime incontinence episodes Standard Error 0.0	-0.2 nighttime incontinence episodes Standard Error 0.1	-0.2 nighttime incontinence episodes Standard Error 0.1	—	-0.2 nighttime incontinence episodes Standard Error 0.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days	1.3 Dry Days Standard Error 0.3	1.5 Dry Days Standard Error 0.8	1.6 Dry Days Standard Error 0.7	—	1.7 Dry Days Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days	0.4 Dry Nights Standard Error 0.2	-0.1 Dry Nights Standard Error 0.4	0.4 Dry Nights Standard Error 0.4	—	0.7 Dry Nights Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	-1.1 micturitions Standard Error 0.2	-0.6 micturitions Standard Error 0.5	-0.4 micturitions Standard Error 0.4	—	-0.8 micturitions Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline and week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=71 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours	-1.2 daytime micturitions Standard Error 0.2	-0.5 daytime micturitions Standard Error 0.5	-0.3 daytime micturitions Standard Error 0.5	—	-1.1 daytime micturitions Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=71 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=21 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=70 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours	-0.1 nighttime micturitions Standard Error 0.1	0.4 nighttime micturitions Standard Error 0.3	0.1 nighttime micturitions Standard Error 0.3	—	0.0 nighttime micturitions Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method.

Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=20 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=19 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents	-1.0 urgency episodes Standard Error 0.5	—	—	—	-0.7 urgency episodes Standard Error 0.5

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known.

Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=16 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=6 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Maximum Concentration (Cmax) of Solifenacin	26.24 ng/mL Standard Deviation 6.617	17.08 ng/mL Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had Cmax measured.	33.48 ng/mL Standard Deviation 11.93	42.85 ng/mL Standard Deviation 21.44	16.67 ng/mL Standard Deviation 4.593

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=16 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=6 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Time to Attain Maximum Concentration (Tmax) of Solifenacin	3.175 hours Standard Deviation 0.561	2.8 hours Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had Tmax measured.	2.874 hours Standard Deviation 0.5268	2.85 hours Standard Deviation 0.4733	2.933 hours Standard Deviation 0.5354

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=16 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=6 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin	16.1 ng/mL Standard Deviation 4.951	8.828 ng/mL Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had Ctrough measured.	19.05 ng/mL Standard Deviation 8.7	27.94 ng/mL Standard Deviation 16.76	9.534 ng/mL Standard Deviation 3.083

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=17 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=8 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin	452.8 ng*h/mL Standard Deviation 112.6	269.2 ng*h/mL Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had AUCtau measured.	560 ng*h/mL Standard Deviation 216.8	745.7 ng*h/mL Standard Deviation 411	298.7 ng*h/mL Standard Deviation 80.35

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=17 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=8 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin	30.98 hours Standard Deviation 7.147	24.84 hours Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had t1/2 measured.	26.85 hours Standard Deviation 7.475	41.27 hours Standard Deviation 17.44	27.3 hours Standard Deviation 5.486

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=17 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=8 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Apparent Total Body Clearance (CL/F) of Solifenacin	7.608 L/h Standard Deviation 1.782	14.56 L/h Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had CL/F measured.	8.773 L/h Standard Deviation 3.763	11.3 L/h Standard Deviation 7.294	6.968 L/h Standard Deviation 2.129

SECONDARY outcome

Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Population: The study analysis population for this endpoint consisted of the PKAS.

Pharmacokinetic sampling was performed at steady state at the end of treatment.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=12 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=1 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=46 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 n=17 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=8 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Apparent Volume of Distribution (Vz/F) of Solifenacin	329.5 L Standard Deviation 63.32	521.9 L Standard Deviation NA Standard deviation is not applicable, only one adolescent participant received PED 7.5 that had Vz/F measured.	315.7 L Standard Deviation 96.23	561.7 L Standard Deviation 181.7	272.4 L Standard Deviation 96.84

SECONDARY outcome

Timeframe: From the first dose of study drug until 7 days after last dose of study medication (13 weeks).

Population: The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug.

A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=22 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Number of Participants With Adverse Events (AEs) Drug-related TEAEs Leading to Permanent Discont.	3 participants	1 participants	1 participants	—	1 participants
Number of Participants With Adverse Events (AEs) Any TEAE	44 participants	12 participants	9 participants	—	45 participants
Number of Participants With Adverse Events (AEs) Drug Related TEAEs	14 participants	2 participants	3 participants	—	9 participants
Number of Participants With Adverse Events (AEs) Deaths	0 participants	0 participants	0 participants	—	0 participants
Number of Participants With Adverse Events (AEs) Serious TEAEs	2 participants	1 participants	1 participants	—	2 participants
Number of Participants With Adverse Events (AEs) Drug-related Serious TEAEs	0 participants	0 participants	0 participants	—	1 participants
Number of Participants With Adverse Events (AEs) TEAEs Leading to Discontinuation	6 participants	2 participants	2 participants	—	1 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The study analysis population for this endpoint consisted of the SAF.

Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.

Outcome measures

Outcome measures
Measure	Children PED 7.5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Adolescents PED 7.5 n=19 Participants Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension	Children PED 10 n=22 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Adolescents PED 10 Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension	Children PED 5 n=73 Participants Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
Change From Baseline in Post Void Residual (PVR) Volume	-0.99 mL Standard Deviation 6.45	-3.58 mL Standard Deviation 4.72	0.95 mL Standard Deviation 9.85	—	0.07 mL Standard Deviation 7.28

Adverse Events

Placebo Children

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Solifenacin Succinate Suspension Children

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo Adolescents

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Solifenacin Succinate Suspension Adolescents

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Children n=73 participants at risk Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Children n=73 participants at risk Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.	Placebo Adolescents n=19 participants at risk Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Adolescents n=22 participants at risk Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
Blood and lymphatic system disorders Lymphadenitis	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Cardiac disorders Tachycardia	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Pyelonephritis	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Nervous system disorders Frontal lobe epilepsy	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Vascular disorders Hypertension	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Gastrointestinal disorders Abdominal pain	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Appendicitis	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	4.5% 1/22 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).

Other adverse events

Additional Information

Medical Director, Medical Science - Urology

Astellas Pharma Europe B.V.

Email: [email protected]

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. Sponsor may delay the publication temporarily to seek patent protection or permanently withhold the publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo Children n=73 participants at risk Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Children n=73 participants at risk Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.	Placebo Adolescents n=19 participants at risk Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.	Solifenacin Succinate Suspension Adolescents n=22 participants at risk Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
Respiratory, thoracic and mediastinal disorders Allergic respiratory symptom	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	4.5% 1/22 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Tooth abscess	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Upper respiratory tract infection	2.7% 2/73 • Number of events 4 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	10.5% 2/19 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Nervous system disorders Dizziness	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Nervous system disorders Somnolence	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Renal and urinary disorders Dysuria	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	15.8% 3/19 • Number of events 3 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Gastrointestinal disorders Constipation	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.5% 4/73 • Number of events 4 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Gastrointestinal disorders Diarrhoea	5.5% 4/73 • Number of events 4 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.5% 4/73 • Number of events 4 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	9.1% 2/22 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Influenza	5.5% 4/73 • Number of events 4 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/19 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	4.5% 1/22 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Nasopharyngitis	9.6% 7/73 • Number of events 8 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	8.2% 6/73 • Number of events 6 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	10.5% 2/19 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Investigations Electrocardiogram QT prolonged	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	6.8% 5/73 • Number of events 5 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	9.1% 2/22 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Nervous system disorders Headache	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	6.8% 5/73 • Number of events 7 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Eye disorders Vision blurred	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Gastrointestinal disorders Abdominal pain	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	10.5% 2/19 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Gastrointestinal disorders Dry mouth	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Immune system disorders Hypersensitivity	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Bronchitis	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	1.4% 1/73 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Escherichia urinary tract infection	2.7% 2/73 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	4.1% 3/73 • Number of events 3 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	10.5% 2/19 • Number of events 2 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Infections and infestations Streptococcal infection	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/73 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	5.3% 1/19 • Number of events 1 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).	0.00% 0/22 • From the first dose of study drug until 7 days after last dose of study medication (13 weeks).