Trial Outcomes & Findings for Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder (NCT NCT01260311)

Last Updated: 2014-09-11

Results Overview

Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).

Recruitment status

COMPLETED

Target enrollment

508 participants

Primary outcome timeframe

Baseline up to 28 days after last dose

Results posted on

2014-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Fesoterodine Fumarate Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
Overall Study STARTED	508
Overall Study COMPLETED	381
Overall Study NOT COMPLETED	127

Reasons for withdrawal

Reasons for withdrawal
Measure	Fesoterodine Fumarate Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
Overall Study Adverse Event	11
Overall Study Lack of Efficacy	4
Overall Study Lost to Follow-up	25
Overall Study Withdrawal by Subject	6
Overall Study Financial Constraints	77
Overall Study Gone to Province	2
Overall Study Medication Stopped	1
Overall Study Fesoterodine Started Before Enrollment	1

Baseline Characteristics

Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fesoterodine Fumarate n=508 Participants Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
Age, Continuous	54.5 years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants
Sex: Female, Male Male	309 Participants n=5 Participants
Weight	64.1 kilogram (kg) STANDARD_DEVIATION 11.4 • n=5 Participants
Body Mass Index	24.1 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.1 • n=5 Participants
Height	163.2 centimeter (cm) STANDARD_DEVIATION 10.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose

Population: Safety population defined as all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Fesoterodine Fumarate n=508 Participants Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with AEs, all-causality	21 participants
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with AEs, treatment-related	19 participants
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with serious AEs, all-causality	0 participants
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with serious AEs, treatment-related	0 participants
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with severe AEs, all-causality	2 participants
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment Participants with severe AEs, treatment-related	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.

Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.

Urgency episodes were defined as micturitions with USS rating of greater than or equal to (\>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.

UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.

PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.

Outcome measures

Outcome data not reported

Adverse Events

Fesoterodine Fumarate

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fesoterodine Fumarate n=508 participants at risk Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
Cardiac disorders Palpitations	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Dry eye	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	2.0% 10/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.39% 2/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.79% 4/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.39% 2/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Agitation	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	0.20% 1/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	0.39% 2/508 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER