Trial Outcomes & Findings for A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076 (NCT NCT01655069)

Last Updated: 2024-11-13

Results Overview

The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

148 participants

Primary outcome timeframe

From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).

Results posted on

2024-11-13

Participant Flow

Participants recruited for this study were children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder (OAB), who completed the 2-week placebo run-in period and 12-week treatment period of Study 905-CL-076 (NCT01565707).

Children and adolescents with OAB, who completed study 905-CL-076, consented to enter this study and fulfilled all the eligibility criteria were enrolled at Week 12/13 (2-3 days after last dose was received during the 905-CL-076 study). The age of participant at informed consent signing in 905-CL-076 determined the age group in this study.

Participant milestones

Participant milestones
Measure	Children Treated With Placebo in 905-CL-076 Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Children Treated With Solifenacin in 905-CL-076 Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Adolescents Treated With Placebo in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Adolescents Treated With Solifenacin in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Overall Study STARTED	61	58	14	15
Overall Study Safety Analysis Set (SAF)	61	57	14	15
Overall Study Full Analysis Set (FAS)	60	57	14	15
Overall Study COMPLETED	53	46	12	11
Overall Study NOT COMPLETED	8	12	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Children Treated With Placebo in 905-CL-076 Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Children Treated With Solifenacin in 905-CL-076 Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Adolescents Treated With Placebo in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Adolescents Treated With Solifenacin in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Overall Study Physician Decision	0	0	0	1
Overall Study Adverse Event	6	7	2	3
Overall Study Lack of Efficacy	0	1	0	0
Overall Study No Treatment Needed	0	1	0	0
Overall Study Withdrawal by Subject	2	3	0	0

Baseline Characteristics

The row for children only includes data for children. The row for adolescents only includes data for adolescents.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children Treated With Placebo in 905-CL-076 n=61 Participants Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Children Treated With Solifenacin in 905-CL-076 n=57 Participants Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Adolescents Treated With Placebo in 905-CL-076 n=14 Participants Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Adolescents Treated With Solifenacin in 905-CL-076 n=15 Participants Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Total n=147 Participants Total of all reporting groups
Age, Continuous Children	7.2 Years STANDARD_DEVIATION 1.6 • n=61 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.	7.5 Years STANDARD_DEVIATION 1.5 • n=57 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.	—	—	7.3 Years STANDARD_DEVIATION 1.6 • n=118 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.
Age, Continuous Adolescents	—	—	13.9 Years STANDARD_DEVIATION 1.6 • n=14 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.	14.5 Years STANDARD_DEVIATION 1.8 • n=15 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.	14.2 Years STANDARD_DEVIATION 1.7 • n=29 Participants • The row for children only includes data for children. The row for adolescents only includes data for adolescents.
Sex: Female, Male Female	27 Participants n=61 Participants	34 Participants n=57 Participants	13 Participants n=14 Participants	11 Participants n=15 Participants	85 Participants n=147 Participants
Sex: Female, Male Male	34 Participants n=61 Participants	23 Participants n=57 Participants	1 Participants n=14 Participants	4 Participants n=15 Participants	62 Participants n=147 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=61 Participants	7 Participants n=57 Participants	2 Participants n=14 Participants	1 Participants n=15 Participants	17 Participants n=147 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=61 Participants	50 Participants n=57 Participants	12 Participants n=14 Participants	14 Participants n=15 Participants	130 Participants n=147 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=61 Participants	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=61 Participants	3 Participants n=57 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	7 Participants n=147 Participants
Race (NIH/OMB) Asian	4 Participants n=61 Participants	5 Participants n=57 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	11 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=61 Participants	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Black or African American	2 Participants n=61 Participants	2 Participants n=57 Participants	1 Participants n=14 Participants	2 Participants n=15 Participants	7 Participants n=147 Participants
Race (NIH/OMB) White	49 Participants n=61 Participants	47 Participants n=57 Participants	11 Participants n=14 Participants	12 Participants n=15 Participants	119 Participants n=147 Participants
Race (NIH/OMB) More than one race	0 Participants n=61 Participants	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=61 Participants	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	3 Participants n=147 Participants

PRIMARY outcome

Timeframe: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).

Population: Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=118 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 Participants Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) TEAE - Mild	72 Participants	10 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) TEAE - Moderate	20 Participants	8 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) TEAE - Severe	1 Participants	2 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Any TEAE	93 Participants	20 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Drug-related TEAEs	41 Participants	11 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Deaths	0 Participants	0 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Serious TEAEs	1 Participants	1 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Drug-related serious TEAEs	0 Participants	0 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to discontinuation	12 Participants	5 Participants
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Drug related TEAEs leading to permanent discont.	12 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

Population: Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.

The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=117 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 Participants Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 3 weeks solifenacin treatment	-0.92 incontinence episodes Standard Error 0.18	-1.05 incontinence episodes Standard Error 0.34
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 6 weeks solifenacin treatment	-1.11 incontinence episodes Standard Error 0.17	-1.40 incontinence episodes Standard Error 0.33
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 9 weeks solifenacin treatment	-1.28 incontinence episodes Standard Error 0.19	-1.48 incontinence episodes Standard Error 0.38
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 12 weeks solifenacin treatment	-1.39 incontinence episodes Standard Error 0.20	-1.66 incontinence episodes Standard Error 0.39
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 24 weeks solifenacin treatment	-1.61 incontinence episodes Standard Error 0.19	-1.73 incontinence episodes Standard Error 0.39
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 40 weeks solifenacin treatment	-1.66 incontinence episodes Standard Error 0.23	-1.49 incontinence episodes Standard Error 0.36
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours 52 weeks solifenacin treatment	-1.56 incontinence episodes Standard Error 0.22	-1.34 incontinence episodes Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=117 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 Participants Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 6 weeks solifenacin treatment	1.28 days Standard Error 0.19	2.21 days Standard Error 0.56
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 3 weeks solifenacin treatment	1.17 days Standard Error 0.16	1.69 days Standard Error 0.53
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 9 weeks solifenacin treatment	1.59 days Standard Error 0.21	1.94 days Standard Error 0.50
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 12 weeks solifenacin treatment	1.60 days Standard Error 0.21	2.89 days Standard Error 0.51
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 24 weeks solifenacin treatment	2.09 days Standard Error 0.22	3.19 days Standard Error 0.51
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 40 weeks solifenacin treatment	2.15 days Standard Error 0.25	2.71 days Standard Error 0.59
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days 52 weeks solifenacin treatment	2.57 days Standard Error 0.40	3.27 days Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=117 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 Participants Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Change From Baseline in Mean Number of Micturitions Per 24 Hours 3 weeks solifenacin treatment	-0.78 micturitions Standard Error 0.18	-1.29 micturitions Standard Error 0.39
Change From Baseline in Mean Number of Micturitions Per 24 Hours 6 weeks solifenacin treatment	-0.96 micturitions Standard Error 0.20	-1.38 micturitions Standard Error 0.63
Change From Baseline in Mean Number of Micturitions Per 24 Hours 9 weeks solifenacin treatment	-1.15 micturitions Standard Error 0.20	-1.15 micturitions Standard Error 0.61
Change From Baseline in Mean Number of Micturitions Per 24 Hours 12 weeks solifenacin treatment	-1.09 micturitions Standard Error 0.21	-1.24 micturitions Standard Error 0.49
Change From Baseline in Mean Number of Micturitions Per 24 Hours 24 weeks solifenacin treatment	-1.42 micturitions Standard Error 0.21	-1.01 micturitions Standard Error 0.49
Change From Baseline in Mean Number of Micturitions Per 24 Hours 40 weeks solifenacin treatment	-1.43 micturitions Standard Error 0.24	-1.39 micturitions Standard Error 0.75
Change From Baseline in Mean Number of Micturitions Per 24 Hours 52 weeks solifenacin treatment	-1.80 micturitions Standard Error 0.43	-0.81 micturitions Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=29 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 3 weeks solifenacin treatment	-0.79 urgency episodes Standard Error 0.26	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 6 weeks solifenacin treatment	-1.36 urgency episodes Standard Error 0.53	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 9 weeks solifenacin treatment	-1.15 urgency episodes Standard Error 0.54	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 12 weeks solifenacin treatment	-1.31 urgency episodes Standard Error 0.38	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 24weeks solifenacin treatment	-1.11 urgency episodes Standard Error 0.47	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 40 weeks solifenacin treatment	-2.18 urgency episodes Standard Error 0.81	—
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents 52 weeks solifenacin treatment	-1.87 urgency episodes Standard Error 0.44	—

SECONDARY outcome

Timeframe: Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)

Population: Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.

PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.

Outcome measures

Outcome measures
Measure	Children (Aged 5 to Less Than 12 Years) n=118 Participants Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 Participants Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume	1.3 mL Standard Deviation 11.9	0.7 mL Standard Deviation 8.8

Adverse Events

Children (Aged 5 to Less Than 12 Years

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Adolescents (Aged 12 to Less Than 18 Years)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Children (Aged 5 to Less Than 12 Years n=118 participants at risk Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 participants at risk Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Infections and infestations Gastroenteritis	0.85% 1/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	0.00% 0/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Appendicitis	0.00% 0/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	3.4% 1/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.

Other adverse events

Other adverse events
Measure	Children (Aged 5 to Less Than 12 Years n=118 participants at risk Children aged 5 to less than 12 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.	Adolescents (Aged 12 to Less Than 18 Years) n=29 participants at risk Adolescents aged 12 to less than 18 years old with OAB who received placebo or solifenacin in 905-CL-076, received a weight-based dose of open-label solifenacin oral suspension once daily for 40 weeks in this study. At the start of the 12-week titration period, the dose was adjusted according to the weight of the participant in order to deliver a plasma drug exposure equivalent to the 2.5 mg, 5 mg, 7.5 mg and 10 mg once daily oral tablet dose of solifenacin in adults.
Investigations Electrocardiogram QT prolonged	8.5% 10/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	13.8% 4/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Immune system disorders Seasonal allergy	0.85% 1/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Nervous system disorders Headache	13.6% 16/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	3.4% 1/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
General disorders Pyrexia	7.6% 9/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	0.00% 0/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Gastrointestinal disorders Abdominal pain upper	5.9% 7/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	3.4% 1/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Gastrointestinal disorders Constipation	13.6% 16/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	3.4% 1/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Gastrointestinal disorders Diarrhoea	5.9% 7/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Gastrointestinal disorders Abdominal pain	2.5% 3/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Gastrointestinal disorders Nausea	2.5% 3/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	10.3% 3/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Escherichia urinary tract infection	5.9% 7/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Gastroenteritis	9.3% 11/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Nasopharyngitis	13.6% 16/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	13.8% 4/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Urinary tract infection	5.1% 6/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	6.9% 2/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.
Infections and infestations Influenza	3.4% 4/118 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.	10.3% 3/29 • From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). (1) For participants who received placebo in 905-CL-076, a TEAE was defined as any AE that started or worsened after the first dose of open-label solifenacin in 905-CL-077 and up to 7 days after the last dose of open-label solifenacin; (2) For subjects who received solifenacin in 905-CL-076, a TEAE is defined as any AE that started or worsened after the first dose of double-blind solifenacin in 905-CL-076 and up to 7 days after the last dose of open-label solifenacin.

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