Trial Outcomes & Findings for A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity (NCT NCT01565694)

NCT ID: NCT01565694

Last Updated: 2024-11-14

Results Overview

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2024-11-14

Participant Flow

The study population consisted of male and female participants with neurogenic detrusor overactivity (NDO) aged 5 years to < 18 years old.

After screening and a 14-day washout period, participants were treated with sequential doses of solifenacin oral suspension for 12 weeks (titration period) to determine each participant's optimal dose, after which a fixed dose of solifenacin oral suspension was given for at least 40 weeks (fixed dose assessment period).

Participant milestones

Measure	Solifenacin Succinate Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during dose-titration period. After completing dose titration period, participants entered fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Dose-Titration Period STARTED	76
Dose-Titration Period COMPLETED	62
Dose-Titration Period NOT COMPLETED	14
Fixed-Dose Assessment Period STARTED	62
Fixed-Dose Assessment Period COMPLETED	58
Fixed-Dose Assessment Period NOT COMPLETED	4

Reasons for withdrawal

Measure	Solifenacin Succinate Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during dose-titration period. After completing dose titration period, participants entered fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Dose-Titration Period Adverse Event	4
Dose-Titration Period Protocol Violation	10
Fixed-Dose Assessment Period Withdrawal by Subject	4

Baseline Characteristics

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Baseline characteristics by cohort

Measure	Solifenacin Succinate n=76 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify optimal dose during the dose-titration period. After the dose titration period participants entered the fixed-dose period and received a fixed dose of solifenacin once a day orally for 40 weeks or until the end of study visit (Week 52).
Age, Continuous	10.8 Years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity Hispanic or Latino	11 Participants n=5 Participants
Ethnicity Not Hispanic or Latino	65 Participants n=5 Participants
Race White	45 Participants n=5 Participants
Race Black/African American	2 Participants n=5 Participants
Race Asian	23 Participants n=5 Participants
Race American Indian/Alaskan Native	1 Participants n=5 Participants
Race Other	5 Participants n=5 Participants
Weight	38.1 kilogram (kg) STANDARD_DEVIATION 15.5 • n=5 Participants
Height	138 centimeters (cm) STANDARD_DEVIATION 16.3 • n=5 Participants
Body Mass Index (BMI)	19.2 (kg/m^2) STANDARD_DEVIATION 4.69 • n=5 Participants
Duration of Neurogenic Detrusor Overactivity (NDO) Disease	8.24 Years n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.

Outcome measures

Measure	Solifenacin Succinate n=55 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) Change from Baseline Week 24	57.2 mL Standard Deviation 107.7
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) Change from Baseline Week 24 (LOCF)	59.3 mL Standard Deviation 107.5

SECONDARY outcome

Timeframe: Baseline, Week 9 or Week 12

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. The number of participant analyzed represents participants with a non-missing change from baseline to last possible titration step.

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.

Outcome measures

Measure

Solifenacin Succinate n=50 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).

Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity

57.4 mL Standard Deviation 105.5

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Bladder Compliance Change from Baseline Week 24	9.1 mL/cmH2O Standard Deviation 28.6
Change From Baseline in Bladder Compliance Change from Baseline Week 24 (LOCF)	8.8 mL/cmH2O Standard Deviation 27.8

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.

Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.

Outcome measures

Measure

Solifenacin Succinate n=50 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).

Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)

23.10 Percentage of EBC Interval -117.2 to 114.7

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 30 cmH20 detrusor pressure were included in the analysis.

Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

Outcome measures

Measure	Solifenacin Succinate n=25 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure Change from Baseline Week 24	61.8 mL Standard Deviation 80.6
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure Change from Baseline Week 24 (LOCF)	71.9 mL Standard Deviation 88.3

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 40 cmH20 detrusor pressure were included in the analysis.

Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

Outcome measures

Measure	Solifenacin Succinate n=18 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure Change from Baseline Week 24	67.0 mL Standard Deviation 44.3
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure Change from Baseline Week 24 (LOCF)	54.4 mL Standard Deviation 52.9

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling Change from Baseline Week 24	-2.3 Detrusor Contractions Standard Deviation 5.1
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling Change from Baseline Week 24 (LOCF)	-1.8 Detrusor Contractions Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.

Outcome measures

Measure	Solifenacin Succinate n=51 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Detrusor Pressure at the End of Bladder Filling Change from Baseline Week 24	-9.2 cmH2O Standard Deviation 33.6
Change From Baseline in Detrusor Pressure at the End of Bladder Filling Change from Baseline Week 24 (LOCF)	-8.2 cmH2O Standard Deviation 32.2

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Average Catheterized Volume Per Catheterization Change from Baseline Week 24	46.23 mL Standard Deviation 48.32
Change From Baseline in Average Catheterized Volume Per Catheterization Change from Baseline Week 24 (LOCF)	48.86 mL Standard Deviation 50.98

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Maximum Catheterized Volume Change from Baseline Week 24	67.45 mL Standard Deviation 88.07
Change From Baseline in Maximum Catheterized Volume Change from Baseline Week 24 (LOCF)	69.63 mL Standard Deviation 88.84

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Average First Morning Catheterized Volume Change from Baseline Week 24	43.24 mL Standard Deviation 72.78
Change From Baseline in Average First Morning Catheterized Volume Change from Baseline Week 24 (LOCF)	44.21 mL Standard Deviation 73.40

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Change from Baseline Week 24	-1.60 Incontinence Episodes Standard Deviation 2.04
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Change from Baseline Week 24 (LOCF)	-1.62 Incontinence Episodes Standard Deviation 2.04

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The number of incontinence-free days was calculated from the 7-day micturition diary.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days Change from Baseline Week 24 (LOCF)	1.19 Days Standard Deviation 2.86
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days Change from Baseline Week 24	1.06 Days Standard Deviation 2.83

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The number of incontinence-free nights was calculated from the 7-day micturition diary.

Outcome measures

Measure	Solifenacin Succinate n=54 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days Change from Baseline Week 24	1.60 Nights Standard Deviation 3.08
Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days Change from Baseline Week 24 (LOCF)	1.64 Nights Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.

Outcome measures

Measure	Solifenacin Succinate n=55 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score) Change from Baseline Week 24	-0.7 Units on a Scale Standard Deviation 8.3
Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score) Change from Baseline Week 24 (LOCF)	-0.7 Units on a Scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline to End of Study Visit (Week 52)

Population: The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.

A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.

Outcome measures

Measure	Solifenacin Succinate n=76 Participants Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Number of Participants With Adverse Events TEAEs	51 Participants
Number of Participants With Adverse Events Drug related TEAE	15 Participants
Number of Participants With Adverse Events Deaths	0 Participants
Number of Participants With Adverse Events Serious TEAEs	7 Participants
Number of Participants With Adverse Events Drug related Serious TEAEs	0 Participants
Number of Participants With Adverse Events TEAEs Leading to Discontinuation	4 Participants
Number of Participants With Adverse Events Drug related TEAEs Leading to Discontinuation	3 Participants

Adverse Events

Solifenacin Succinate

Serious events: 7 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Solifenacin Succinate n=76 participants at risk Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Cardiac disorders Tachycardia	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Gastrointestinal disorders Megacolon	1.3% 1/76 • Number of events 2 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Dengue fever	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Orchitis	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Urinary tract infection bacterial	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Nervous system disorders Tethered cord syndrome	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Surgical and medical procedures Spinal cord operation	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).
Vascular disorders Hypertension	1.3% 1/76 • Number of events 1 • From the first dose of study drug to the last dose of study drug (up to week 52).

Other adverse events

Measure	Solifenacin Succinate n=76 participants at risk Participants aged 5 years to \< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Gastrointestinal disorders Constipation	7.9% 6/76 • Number of events 10 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Escherichia urinary tract infection	7.9% 6/76 • Number of events 7 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Nasopharyngitis	5.3% 4/76 • Number of events 5 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Upper respiratory tract infection	5.3% 4/76 • Number of events 6 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Urinary tract infection	15.8% 12/76 • Number of events 12 • From the first dose of study drug to the last dose of study drug (up to week 52).
Infections and infestations Urinary tract infection bacterial	18.4% 14/76 • Number of events 17 • From the first dose of study drug to the last dose of study drug (up to week 52).
Investigations Electrocardiogram QT prolonged	5.3% 4/76 • Number of events 4 • From the first dose of study drug to the last dose of study drug (up to week 52).
Nervous system disorders Headache	5.3% 4/76 • Number of events 4 • From the first dose of study drug to the last dose of study drug (up to week 52).
Renal and urinary disorders Bladder pain	5.3% 4/76 • Number of events 4 • From the first dose of study drug to the last dose of study drug (up to week 52).
Respiratory, thoracic and mediastinal disorders Cough	5.3% 4/76 • Number of events 4 • From the first dose of study drug to the last dose of study drug (up to week 52).
Skin and subcutaneous tissue disorders Decubitus ulcer	5.3% 4/76 • Number of events 4 • From the first dose of study drug to the last dose of study drug (up to week 52).

Additional Information

Clinical Trial Disclosure

Astellas Pharma Europe B.V.

Phone: 310715455050

Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor at least 1 month prior to the submission of any such information to an editorial board or scientific review committee. This allows the Sponsor to protect proprietary information and to provide comments based on information from other studies that may not yet be available to the investigator.
• Publication restrictions are in place

Restriction type: OTHER