This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder (NCT01260311), a registered phase not stated study. The primary outcome is Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01260311 |
| Phase | Phase not stated |
| Condition | Over Active Bladder |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 508 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Filipino patients diagnosed with over-active bladder and prescribed fesoterodine. The safety population is defined as participants who received at least one dose of study medication; the adverse-event results list 508 participants at risk.
Intervention
Fesoterodine fumarate, also identified as Toviaz in the registry description. This was an observational study of patients prescribed the drug, rather than a randomized treatment assignment.
Comparator
No like-for-like control group is reported. The record describes one group of patients prescribed fesoterodine, and allocation is not stated. The safety counts therefore describe that group; they do not estimate a contrast with an untreated or alternative-treatment group.
Primary question
How many participants had treatment-emergent adverse events, classified by seriousness, severity, and investigator-assessed relationship to fesoterodine, from baseline through 28 days after the last dose? The primary outcome is a participant count, with repeated occurrences within an AE category counted once for each participant.
3. Trial Design
This was an observational post-marketing surveillance study of fesoterodine in Filipino patients diagnosed with over-active bladder. The registry describes patients prescribed fesoterodine; it does not describe random assignment or a control group. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. The study therefore describes outcomes in the treated group rather than a randomized comparison between treatments.
The registry lists 508 participants enrolled. The safety population is defined as all participants who received at least one dose of study medication, and the adverse-event result lists 508 participants at risk. The record does not provide further detail about recruitment, eligibility criteria, dosing, adherence, follow-up procedures, or the number who completed follow-up.
The study start is listed as 2011-02, primary completion as 2013-10, and status as completed. Its stated purpose was to determine the safety profile of fesoterodine in Filipino patients prescribed the drug, in compliance with requirements of the Philippine Food and Drug Administration. Although the study title and summary refer to safety and efficacy, the primary outcome reported is an adverse-event count. Efficacy results are not reported in the registry record.
The registry lists five outcome measures and zero analyses. A detailed statistical analysis plan, including any prespecified adjustments or procedures for incomplete observations, is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Fesoterodine Fumarate |
|---|---|
| STARTED | 508 |
| COMPLETED | 381 |
| NOT COMPLETED | 127 |
Reasons for not completing this period:
| Reason | Fesoterodine Fumarate |
|---|---|
| Adverse Event | 11 |
| Lack of Efficacy | 4 |
| Lost to Follow-up | 25 |
| Withdrawal by Subject | 6 |
| Financial Constraints | 77 |
| Gone to Province | 2 |
| Medication Stopped | 1 |
| Fesoterodine Started Before Enrollment | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety population defined as all participants who received at least one dose of study medication.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Fesoterodine Fumarate |
|---|---|---|
| Participants analysed | 508 | |
| Age, Continuous | years | 54.5 (SD 15.0) |
| Sex: Female, Male: Female | Participants | 199 |
| Sex: Female, Male: Male | Participants | 309 |
| Weight | kilogram (kg) | 64.1 (SD 11.4) |
| Body Mass Index | kilogram per square meter (kg/m^2) | 24.1 (SD 4.1) |
| Height | centimeter (cm) | 163.2 (SD 10.1) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment, measured over Baseline up to 28 days after last dose.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with treatment-emergent adverse events. An event qualifies as treatment-emergent if it newly occurred or worsened after the first dose. The stated observation window runs from baseline through 28 days after the last dose. The endpoint is a count of participants, not a count of every event occurrence: when a participant had repeated occurrences of an event within a category, that participant was counted once in that category.
The outcome classifies events by seriousness, severity, and relationship to treatment. Seriousness was assessed using serious adverse event criteria. Severity was described as mild when the event caused no significant problem and did not require dose adjustment; moderate when it caused a problem without significant interference in usual activities or clinical status and dose adjustment was needed; and severe when it significantly interfered with usual activities or clinical status and the study drug was stopped because of the event. The investigator assessed relatedness to fesoterodine fumarate.
Participant counts are useful for describing how many people experienced an event, while event counts can be inflated by repeated occurrences in the same person. These counts alone do not establish that treatment caused an event. The registry gives some event counts but does not report the complete breakdown by severity and relatedness.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event results list 0 participants with serious adverse events among 508 at risk and 21 participants with other adverse events among 508 at risk. These are descriptive counts for the fesoterodine group. The registry does not provide a control group suitable for a like-for-like comparison, so the counts cannot be interpreted as a comparative estimate of risk attributable to fesoterodine.
The outcome is defined at the participant level. A participant with multiple occurrences in a category is counted once within that category, so the results do not represent the total number of event episodes. The available results also do not give the categories needed to understand the distribution of events by mild, moderate, or severe intensity, or by investigator-assessed relationship to treatment. Those details are not reported in the registry record.
A count of zero serious adverse events in the recorded group is a description of what was recorded during the specified observation period. It does not establish that serious events cannot occur, nor does it quantify how uncertain the underlying event frequency may be. A confidence interval could express uncertainty around a frequency estimate, but no confidence interval is reported in the registry record. The count also depends on the event definitions, observation period, follow-up, and completeness of event recording.
The 21 participants with other adverse events should likewise be read as a recorded count, not as proof that all such events were caused by treatment. The registry says that the investigator assessed relatedness, but does not provide the relatedness-specific counts. It also does not identify the non-serious event terms in the information reported for this outcome. Consequently, the aggregate count does not show which events occurred or how investigators judged their relationship to fesoterodine.
The record lists five outcome measures but zero analyses. It does not report hypothesis tests, adjusted estimates, or a formal comparison for this primary outcome. The posted numbers therefore support a descriptive account only. They do not establish a treatment effect, and the absence of a reported comparator prevents separating treatment-associated events from events that might occur in this population for other reasons.
9. Statistical Methods Explained
The primary outcome is a binary event outcome at the participant level: each participant either met the definition for an event category during the observation window or did not. The registry reports counts of participants, not a continuous measurement such as a laboratory value. The result is therefore best read as a count in the observed safety population, with the event definitions and time window kept in view.
Why participant counts differ from event counts
A person may have repeated occurrences of an adverse event. Counting every occurrence would answer how many episodes were recorded; counting participants answers how many people had at least one occurrence. The registry specifies that a participant with multiple occurrences within an AE category is counted once in that category. This makes the endpoint a measure of people affected within each category, but it does not describe the number, duration, or recurrence of episodes.
What treatment-emergent means
The registry defines treatment-emergent events as newly occurring or worsening after the first dose. This definition establishes a timing relationship, not by itself a causal relationship. An event may begin after treatment starts without having been caused by treatment. The investigator separately assessed relatedness to fesoterodine fumarate, but the relatedness-specific results are not reported in the registry record.
Seriousness and severity are different classifications
Seriousness uses serious adverse event criteria; severity describes how much the event affected the participant. The registry describes mild, moderate, and severe categories using effects on usual activities or clinical status and whether dose adjustment or stopping study drug was required. These classifications answer different questions, so a severity label should not be treated as interchangeable with serious-event status. The record does not report the full count breakdown across these categories.
Why the design affects interpretation
In an observational surveillance study, treatment is prescribed rather than randomly assigned by the study. This means the recorded event counts describe people who received the medication under the study's conditions, but do not by themselves distinguish treatment effects from other explanations. A randomized control group can support a direct comparison when the groups are appropriately assigned; no such comparison is reported. The registry also states that the arms are not a like-for-like control comparison.
What statistical uncertainty would add
A confidence interval is a range calculated to convey the statistical uncertainty around an estimate. For a participant count expressed as a frequency, an interval can help readers distinguish a precise estimate from one compatible with a wider range of underlying values. No confidence interval is reported for the adverse-event counts, and none should be inferred from the counts alone. A p-value would address a specified statistical test; the registry lists zero analyses and does not report a p-value for this endpoint.
For outcomes with counts, methods must also account for the data structure and the question being asked. A participant-level count is not interchangeable with a rate of event episodes or a time-to-event analysis. The registry does not report a time-to-event analysis for this endpoint. The period is defined relative to dosing, but the record does not give participant-level event times or exposure durations from which such an analysis could be assessed.
The sample-size assumptions described for planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. These are planning assumptions, not evidence that the observational study used a two-arm randomized design. The study record describes a prescribed-treatment group and no like-for-like control comparison. Any resulting sample-size illustration is a planning calculation, not observed power and not a result from the surveillance cohort.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and zero analyses. It does not report whether a multiplicity adjustment was planned or used, how the primary outcome relates to the other outcome measures, or whether any subgroup analyses were prespecified. Without that information, the number of statistical comparisons intended by the study and any adjustment for repeated testing are not reported in the registry record. The posted adverse-event counts are descriptive and should not be read as results of a multiplicity-controlled testing procedure.
Missing-data handling is also not reported in the registry record. The safety population is defined as participants who received at least one dose, and the adverse-event results list 508 participants at risk. The record does not state whether all participants had complete observation through 28 days after their last dose, how participants lost to follow-up were handled, or whether event status was unknown for any participant.
These omissions matter because a participant with incomplete observation may have less opportunity for an event to be recorded than a participant followed throughout the stated period. The counts alone do not show whether follow-up was complete or whether missing information could affect the descriptive results. The protocol's missing-data rules and statistical analysis plan are not reported in the registry record.
No imputation method, sensitivity analysis, or analysis-population comparison is reported. It is therefore not possible to determine from the registry record whether results were checked under alternative assumptions about missing outcomes or whether populations beyond the defined safety population were analyzed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fesoterodine Fumarate | 0 | 508 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fesoterodine Fumarate | 21 of 508 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fesoterodine Fumarate |
|---|---|---|
| Dry mouth | Gastrointestinal disorders | 10 of 508 |
| Vomiting | Gastrointestinal disorders | 4 of 508 |
| Nausea | Gastrointestinal disorders | 2 of 508 |
| Urinary tract infection | Infections and infestations | 2 of 508 |
| Urinary retention | Renal and urinary disorders | 2 of 508 |
| Palpitations | Cardiac disorders | 1 of 508 |
| Dry eye | Eye disorders | 1 of 508 |
| Abdominal pain upper | Gastrointestinal disorders | 1 of 508 |
| Constipation | Gastrointestinal disorders | 1 of 508 |
| Dyspepsia | Gastrointestinal disorders | 1 of 508 |
The serious adverse-event result is 0 participants among 508 at risk. The result for other adverse events is 21 participants among 508 at risk. These are participant counts for the fesoterodine group and refer to the outcome's stated observation period, from baseline through 28 days after the last dose. The endpoint counts a participant once within an event category even when the event occurred more than once.
Seriousness is not the same as severity. The registry defines seriousness using serious adverse event criteria and separately describes mild, moderate, and severe intensity. It also says the investigator assessed relatedness to fesoterodine. The posted result does not give the full breakdown by severity or relatedness. No serious event terms are listed in the registry record.
The count of 0 is not evidence that serious events are impossible, and the count of 21 does not establish that fesoterodine caused the events. There is no suitable control group for comparison, and no uncertainty interval is reported. These figures describe the events recorded in the study group; they do not provide a comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The result gives a descriptive account of adverse events recorded among patients prescribed fesoterodine in this observational surveillance study. In the safety population listed at risk, the registry reports 0 participants with serious adverse events and 21 with other adverse events. The primary endpoint concerns participants with events, rather than the total number of event occurrences, and its window extends from baseline through 28 days after the last dose.
These counts do not answer whether fesoterodine caused an event. Treatment-emergent status describes when an event occurred or worsened, while causal assessment is a separate question. The investigator assessed relatedness, but the relatedness breakdown is not reported. Likewise, the reported counts do not show how events were distributed across mild, moderate, and severe categories.
The study has no reported like-for-like control group, and allocation is not stated. Without a suitable comparison, the observed counts cannot be contrasted with outcomes under another treatment or no treatment. The record also does not report confidence intervals or inferential tests for the primary endpoint. Thus, the results do not quantify comparative risk or establish an efficacy effect.
The findings are specific to the enrolled study group, the safety-population definition, event recording, and the stated follow-up window. They do not establish what would be observed in populations or settings not described in the record. The registry's reference to safety and efficacy in the study title does not substitute for an efficacy result; efficacy findings are not reported in the registry record.
13. Why This Trial Matters Statistically
Post-marketing surveillance addresses adverse events observed among patients prescribed a medication outside a randomized treatment comparison. Such descriptive evidence can characterize what was recorded in a defined patient group and can complement other types of evidence. Its statistical interpretation depends on clear event definitions, a stated population, the observation period, and transparent reporting of the event counts. This record identifies the safety population, defines treatment-emergent events, and specifies the follow-up window.
The distinction between participant counts and event counts is important. The primary outcome counts each participant once within an event category, which describes how many people experienced an event rather than how often episodes occurred. Separating seriousness from severity and treatment relatedness is also important because those classifications describe different aspects of adverse events. The registry defines these concepts, while the posted results do not provide every requested breakdown.
The study also illustrates a central limitation of descriptive safety data: without a suitable comparison group, counts cannot determine how much of the observed experience is attributable to treatment. Reporting a count is informative about the cohort, but it does not supply a comparative effect estimate. Statistical uncertainty and missing follow-up information also matter when interpreting sparse event counts; neither confidence intervals nor missing-data methods are reported in the registry record.
For clinical researchers and biostatisticians, the record therefore offers a useful example of how an endpoint's definition and the design constrain the claims that can be made. It supports description of the recorded events, while leaving causal comparison, precision, and some event classifications unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The observational design does not report random assignment or a suitable control group. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. The event counts therefore cannot serve as a direct comparative estimate against another treatment or an untreated group.
The registry defines the safety population as participants who received at least one dose, and the results list 508 at risk. It does not report detailed follow-up completeness, participant disposition, missing-data procedures, or whether every participant was observed for the full period ending 28 days after the last dose. This limits assessment of whether all participants had comparable opportunity for event detection.
The primary outcome is described by seriousness, severity, and investigator-assessed relationship to treatment, but the reported information does not include the complete breakdown for these classifications. No serious adverse event terms are listed, and the record does not identify the terms for the other adverse events in the reported result. The counts consequently provide limited detail about event type and clinical characterization.
No confidence intervals, hypothesis tests, or other inferential results are reported for the primary endpoint. The registry lists zero analyses, and the statistical analysis plan, multiplicity procedures, and missing-data methods are not reported. The record also lists five outcome measures but does not report efficacy results in the information. These omissions restrict assessment of precision, robustness, and the relationship between the primary outcome and other study outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder — NCT01260311.
- Registry record last updated 2014-09-11; status last verified 2014-09.
- Results first posted 2014-09-11.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed observational post-marketing surveillance study examined fesoterodine in Filipino patients diagnosed with over-active bladder. The registry lists 508 participants enrolled and defines the safety population as participants who received at least one dose. The study's stated purpose was to determine the drug's safety profile in Filipino patients prescribed fesoterodine, in compliance with requirements of the Philippine Food and Drug Administration.
The primary outcome counts participants with treatment-emergent adverse events from baseline through 28 days after the last dose. The results list 0 participants with serious adverse events and 21 with other adverse events among 508 at risk. The record does not report a suitable control comparison, complete severity and relatedness breakdowns, confidence intervals, or inferential analyses. These results describe recorded events in the study group and do not establish causation or comparative treatment effects.