Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice (NCT01793142), a registered phase not stated study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).

2. Clinical Question

This is a descriptive safety question in a post-marketing, usual-practice setting. It concerns the occurrence of events among treated participants; it does not, by itself, establish whether an event was caused by Viviant. The registry also lists efficacy and other safety-related measures, but their results are not reported in the registry record.

3. Trial Design

This completed study is titled “Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice.” Its stated purpose was to assess the safety and efficacy profiles of Viviant in usual practice and prepare application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Osteoporosis is the listed condition, and Pfizer is the sponsor.

The registry lists an enrollment of 3430 and one Viviant treatment group. The study start date was 2013-10-24, and primary completion was 2017-05-31. The status is COMPLETED. The listed intervention is Viviant, and the primary endpoint description specifies the 20 mg tablet.

The registry record does not report allocation, and it does not describe a control group. The study therefore does not offer a randomized comparison in the posted record. The registry itself cautions that the arms are not a like-for-like control comparison. No further design details about participant selection, recruitment, clinical settings, treatment duration, dosing schedules, or follow-up procedures are reported in the registry record.

The primary outcome concerns treatment-emergent adverse events and serious adverse events. The registry also names secondary outcomes concerning overall efficacy evaluation, osteoporosis-related fractures, and abnormal DXA, X-ray, bone mineral density, and biochemical bone-turnover results. Although eight outcome measures are listed in total, the registry record does not report outcome analyses. The record lists zero analyses. No protocol details about how outcomes were assessed or how the survey data were collected are 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

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.

Population: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), measured over Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months).

The primary endpoint is the number of participants with treatment-emergent adverse events and serious adverse events. An adverse event is defined as any untoward medical occurrence in a participant who received the study drug, without regard to whether a causal relationship was considered possible. The endpoint includes both serious and non-serious adverse events.

The registry defines a serious adverse event by its consequences or significance: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, a congenital anomaly, or another event deemed significant for another reason. Treatment-emergent events are those occurring between the first dose and up to 28 days after the last dose of Viviant 20 mg tablet that were absent before treatment or worsened relative to the pre-treatment state. The endpoint timeframe is listed as baseline through up to 28 days after the last dose, described as up to 6 months.

Counting participants with events is a descriptive way to report how many people experienced an event during the specified observation period. It is useful for characterizing safety experience in the treated group, but a count alone does not show when events occurred, how long they lasted, or whether they were caused by treatment. Without a reported control comparison, the count also cannot separate events associated with treatment from events that might occur in the underlying population or usual practice.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry presents the primary endpoint as a count of participants with events. This is a binary outcome at the participant level: for a particular event definition and observation period, a participant either meets the definition or does not. The reported count indicates how many participants were classified as having an event; it does not retain all details about the timing, duration, recurrence, or severity of events. The registry describes the outcome unit as participants.

What does a participant count convey?

A participant count is straightforward to interpret as a tally, but its meaning depends on the population included, the event definition, and the observation period. In this study, the safety analysis set includes people who received Viviant 20 mg at least once and completed follow-up. Treatment-emergent events are defined relative to the pre-treatment state and the period from first dose through up to 28 days after the last dose. The stated timeframe is baseline through that period, up to 6 months. These definitions set the boundaries for interpreting the outcome.

The posted adverse-event summary gives counts for the serious-event field, the other-event field, and deaths. These fields should be read as the registry reports them. The record does not provide a detailed account of overlap among those categories or a full event-by-event accounting for the primary endpoint. It is therefore not appropriate to add the counts together or to infer a total number of unique participants with any adverse event from those fields.

Why does study design matter?

A single treatment group can describe events observed during treatment and follow-up, but it does not create a direct estimate of how event occurrence differs from a comparator. In a randomized comparison, random assignment is intended to make groups comparable on average, which supports interpretation of between-group differences. Here, the registry lists one Viviant group, does not state allocation, and does not report a control group. The adverse-event counts therefore remain descriptive. They cannot by themselves identify a treatment effect or distinguish an effect of treatment from other explanations.

General statistical explanation: an estimate is more informative when its uncertainty is also described. For a participant count or proportion, an interval estimate can communicate the range of values reasonably compatible with the observed data under a stated statistical method. The registry record does not report confidence intervals for these safety counts. No inferential analysis is listed, so there is no posted statistical test or model-based estimate to interpret.

How should planning illustrations be understood?

General statistical explanation: sample-size planning asks how many participants a future study might need to detect a specified effect under assumptions about the design and analysis. Such planning depends on the target effect, significance level, allocation, and statistical approximation. The planning framework associated with this study is described as an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial itself used that design or that it had a particular probability of detecting an effect.

The registry record does not report a sample-size justification for the surveillance study. The record also does not report the observed effect needed to interpret a planning illustration as a concrete scenario, or any planning results in the registry record for this analysis. Any such illustration is distinct from observed power. General statistical explanation: observed power is not a substitute for an uncertainty interval around an observed result; after data collection, the estimate and its precision are the relevant quantities for describing what the data show.

What do multiple outcomes imply?

The registry lists eight outcome measures, including the primary safety endpoint and secondary measures related to overall efficacy, fractures, and abnormal imaging, bone-density, and biochemical-marker results. When a study assesses multiple outcomes, the chance of at least one apparently notable result can depend on how many comparisons are made and how they are analyzed. General statistical explanation: multiplicity procedures can be used to control or describe this issue, but their use depends on the planned questions and analysis strategy. The registry record does not report a multiplicity adjustment or a statistical analysis plan. It also lists zero analyses, so there are no posted analysis results for those outcome measures to interpret.

Other technical details that would inform interpretation, including the approach to missing data, event adjudication, statistical models, and any interim analyses, are not reported in the registry record. These omissions limit assessment of how the posted counts were produced and how robust they are to alternative analytic decisions.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures. These include the primary count of participants with treatment-emergent adverse events and serious adverse events, along with secondary outcomes concerning overall efficacy evaluation, osteoporosis-related fractures, and abnormal DXA, X-ray, bone mineral density, and biochemical bone-turnover results. Assessing several outcomes can create a multiplicity issue: general statistical explanation, the more questions examined, the greater the opportunity for an apparently notable result to arise by chance if each is treated as a separate test. The registry record does not report a plan for controlling or otherwise addressing multiplicity.

The registry lists zero analyses, and results for the listed secondary outcomes are not reported in the registry record. The statistical analysis plan, including any prespecified hierarchy among outcomes or adjustment for multiple testing, is not reported in the registry record. No interim analyses are reported in the registry record.

The safety analysis set included participants who received Viviant 20 mg at least once and completed follow-up. The record does not report how participants with incomplete follow-up were handled, how much information was missing, or whether any imputation or sensitivity analysis was used. The reason the enrollment figure and the number at risk in the adverse-event summary differ is not reported in the registry record. The record also does not describe how missing or uncertain event information was classified.

These omissions matter because the included population and handling of incomplete observations affect what a count represents. The stated safety population gives a boundary for interpreting the reported data, but without further details it is not possible to assess how exclusion or incomplete follow-up may have affected the summaries.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pyelonephritis (0.1%), fracture (0.1%), cerebral infarction (0.1%), spinal stenosis (0.0%), bradycardia (0.0%).

The adverse-event summary lists 3423 participants at risk in the Viviant Tablet 20 mg group. Its serious-event field lists 17 participants, its other-event field lists 192 participants, and it lists 1 death. These are descriptive registry figures. The record does not give a control-group count for comparison, and it does not state that the death was caused by treatment.

The serious-event terms are reported with percentages: PYELONEPHRITIS, FRACTURE, and CEREBRAL INFARCTION each at 0.1%; SPINAL STENOSIS, BRADYCARDIA, and ABDOMINAL PAIN each at 0.0%. The terms and percentages describe the registry’s listing; a displayed 0.0% does not mean that no event occurred, and the record does not provide the underlying term-specific participant counts in the registry record for this analysis.

An adverse event is defined as an untoward medical occurrence after receipt of study drug, regardless of whether a causal relationship was considered possible. Seriousness is defined by specified outcomes or clinical significance, not by proof that treatment caused the event. The counts should therefore be read as reported safety observations, not as causal estimates. Details about overlap between the serious and other fields are not reported in the registry record.

12. What the Result Does, and Does Not, Mean

The posted results describe adverse events among participants in a post-marketing survey of Viviant in usual practice. The registry lists a serious-event count, an other-event count, a death count, and selected serious-event terms with percentages. These figures provide a descriptive account of the events recorded in the treated group. They do not establish that Viviant caused any particular event, nor do they establish that an event would not have occurred without treatment.

There is no listed control group, and the registry record does not report random allocation. Without a suitable comparator, the event counts cannot be interpreted as a difference attributable to treatment. The record also does not report analyses or confidence intervals, so the statistical precision of the counts cannot be judged from inferential results. The listed 0.0% values should be read as the reported rounded percentages, not as proof that the corresponding event was absent.

The stated population is the safety analysis set: participants who received Viviant 20 mg at least once and completed follow-up. The adverse-event summary lists 3423 participants at risk, while the enrollment was 3430. The record does not explain the difference or describe missing follow-up in enough detail to assess its impact. This limits conclusions about how well the reported counts represent all enrolled participants.

The study’s stated purpose included assessing efficacy, and the registry names several efficacy- and safety-related secondary outcomes. Their results are not reported in the registry record. Accordingly, the posted information does not permit conclusions about those outcomes. More generally, the descriptive counts should not be extended beyond the defined population, event definitions, and observation period. They are not a substitute for a comparative analysis, and they do not establish a causal explanation for the observed events.

13. Why This Trial Matters Statistically

Post-marketing surveillance addresses safety and efficacy profiles in usual practice, the setting named for this Viviant survey. Such a setting can describe treatment experience beyond a narrowly specified comparison, but the value of the resulting summaries depends on clear outcome definitions, population rules, follow-up, and analysis methods. This registry record gives a definition of treatment-emergent events and identifies the safety analysis set, which are important details for interpreting the reported counts.

The study also illustrates the distinction between descriptive safety evidence and comparative evidence. The registry lists a single Viviant group, does not state allocation, and provides no like-for-like control comparison. Counts from that group can document what was recorded among treated participants, but they cannot isolate the contribution of treatment from other causes. This is a central statistical limitation when interpreting post-marketing event summaries.

The record names a range of secondary measures, including overall efficacy evaluation, fractures, imaging findings, bone mineral density, and biochemical markers. Yet it lists zero analyses, and results for those measures are not reported in the registry record. The gap between outcome definitions and analyzable results is statistically important: readers need results, uncertainty, and analysis details to evaluate how much the data support a conclusion.

Finally, the registry record shows why counts need context. The safety population is defined by treatment receipt and completed follow-up, and the adverse-event summary gives a number at risk. Information about incomplete follow-up, overlap among event categories, and statistical uncertainty is not reported in the registry record. Recognizing these limits helps keep the interpretation proportional to what the recorded data can establish.

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 registry record provides limited information about the study’s design beyond its post-marketing, usual-practice purpose, listed treatment group, enrollment, dates, and completion status. Allocation is not stated, and no control group is listed. The lack of a like-for-like comparison prevents direct estimation of how event occurrence differed with Viviant versus an alternative or no treatment.

The record defines the safety analysis set as participants who received Viviant 20 mg at least once and completed follow-up. The adverse-event summary lists 3423 participants at risk, compared with enrollment of 3430. Why these figures differ is not reported in the registry record. Details about losses to follow-up, missing observations, participant exclusions, and their possible effect on the results are not reported in the registry record.

The registry lists the serious and other adverse-event fields, deaths, and selected serious-event terms, but it does not provide detail about overlap between event categories or a full account of event-level timing and duration. Whether the death was considered treatment-related is not reported in the registry record. The listed adverse events are not, by definition, proof of a causal relationship.

The record lists eight outcome measures but zero analyses. Results for the secondary outcomes, confidence intervals, statistical tests, and the statistical analysis plan are not reported in the registry record. The approach to multiplicity, interim analyses, sample-size justification, and detailed data-collection or event-adjudication procedures is also not reported in the registry record. These limitations restrict assessment of precision, completeness, and analytic choices.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice — NCT01793142.
• Registry record last updated 2018-12-24; status last verified 2018-05.
• Results first posted 2018-12-24.
• 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.

18. Record Summary

This completed post-marketing surveillance study assessed Viviant in usual practice for osteoporosis. Pfizer is listed as the sponsor. Enrollment was 3430; the study started 2013-10-24 and reached primary completion on 2017-05-31. The registry lists one Viviant treatment group and does not report a comparator or allocation.

The primary endpoint was the number of participants with treatment-emergent adverse events and serious adverse events. The safety analysis set comprised participants who received Viviant 20 mg at least once and completed follow-up. The adverse-event summary lists 3423 participants at risk, 17 in the serious-event field, 192 in the other-event field, and 1 death. Selected serious-event terms and percentages are also listed.

Eight outcome measures are listed, but the record lists zero analyses. Results for the secondary outcomes, inferential analyses, and further statistical methods are not reported in the registry record. The adverse-event figures are descriptive and do not establish causation or a comparative treatment effect.