Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive (NCT02792504), a registered phase not stated study. The primary outcome is Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

2. Clinical Question

3. Trial Design

The registry identifies this as a completed post-marketing surveillance study titled “Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive.” Its stated aim was to evaluate the safety and efficacy of CE/BZA in real practice in Korea. The listed condition is severe vasomotor symptom associated with menopause. Pfizer is named as sponsor. The study start date is 2016-03-29, and the primary completion date is 2020-07-22.

The record describes a Duavive group, with 639 participants at risk in the posted adverse-event results. The registry reports 669 enrolled participants, while the safety analysis set is defined as participants who had received Duavive at least once and completed follow-up. These are separately reported quantities with different descriptions; the record does not explain their relationship in further detail. In particular, it does not provide a participant-flow account explaining exclusions or follow-up completion.

This was not a randomized comparison, and allocation is not stated. A control group or a like-for-like comparison is not described in the registry record. Consequently, the design information supports a descriptive account of events recorded among Duavive recipients, but not a randomized estimate comparing treatment with another option. The registry record does not report further details about recruitment, site structure, eligibility criteria beyond the condition listed, or the conduct of follow-up.

The primary outcome was the number of participants with adverse events and serious adverse events. Its timeframe ran from baseline through 28 days after the last dose, with follow-up lasting up to 22 months. Nine outcome measures are listed in the record, but details for the other outcomes are not part of the registry entries. The registry record reports no analyses. It does not report a statistical analysis plan, sample-size justification, interim analyses, or additional design information.

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.

Before assignment: In this study no screening was performed. Women participants who were administered Duavive tablet were enrolled.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed 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 those participants who had been administered with Duavive tablet at least once and had completed follow up.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), measured over Baseline up to 28 days after last dose of study drug (up to 22 months).

The primary endpoint counts participants with adverse events and serious adverse events. The registry defines an adverse event as any untoward medical occurrence in a participant who received the investigational product, without regard to whether a causal relationship was considered possible. Serious adverse events are events resulting in, or considered significant for, outcomes such as death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, congenital anomaly, or another medically important event. The definition includes serious and non-serious adverse events.

The stated observation period begins at baseline and continues through 28 days after the last dose, for up to 22 months. The safety analysis set includes participants who received at least one Duavive tablet and completed follow-up. This endpoint is used to describe the frequency of participants recorded as experiencing events during that period. In general, counting participants rather than event episodes can help express how many people were affected, while not describing how often an individual experienced events or how long they lasted.

The endpoint is a safety measure, not a direct measure of treatment benefit. Because the definition does not require an event to be attributed to treatment, the count should not be read as proof that treatment caused the event. Without a randomized comparison, the endpoint also cannot establish whether the observed event counts differ from what would have occurred under another treatment or without treatment. The registry record does not report further endpoint adjudication procedures or additional rules for handling repeated events.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Interpreting a safety result begins with understanding what was counted. The primary outcome is the number of participants with adverse events and serious adverse events. It is a binary-type outcome at the participant level: for an event category, a participant either appears as having an event or does not. The posted figures are counts, not measurements of symptom intensity, event duration, or repeated episodes. The registry record does not report additional detail about how repeat events in one participant were represented in the summary.

What does a participant count tell the reader?

In general, a participant count is a direct descriptive summary of how many people were recorded with an event. It can be useful for communicating the scale of reported safety experience in a monitored group. It does not, alone, give a complete account of risk. The denominator, eligibility for the analysis set, follow-up period, event definitions, and completeness of observation all affect interpretation. Here, the registry lists 639 participants at risk in the adverse-event group and defines the safety set as people who received at least one tablet and completed follow-up. It separately reports 669 enrolled participants. The record does not explain the participant flow between those entries.

In general, a rate or proportion expresses a count relative to a specified denominator. No new proportion should be inferred from counts without a clearly defined analysis and denominator. The serious and other adverse-event counts are reported as participant counts, while the serious-event terms are listed with percentages. Their meaning depends on the registry's conventions; further denominator details for the term percentages are not reported in the registry record. The percentages should therefore be read as presented rather than treated as independently reconstructed values.

Why does the definition of an adverse event matter?

The registry definition captures any untoward medical occurrence after a participant received the investigational product, regardless of whether a causal relationship was considered possible. This broad approach is useful for surveillance because it does not restrict collection to events already judged to be treatment-related. It also means that an event count is not equivalent to a count of events caused by the treatment. Attribution requires evidence and assessment beyond the mere temporal observation that an event occurred during the follow-up period.

Seriousness is defined by outcomes or medical significance, including death, hospitalization, life-threatening experience, persistent or significant disability or incapacity, congenital anomaly, or medically important events. Seriousness is not the same concept as causal attribution. An event can meet the seriousness definition without being judged treatment-related, and an event that is not serious can still be relevant to safety. The record's primary outcome includes both serious and non-serious adverse events.

What does a confidence interval generally add?

In general, a confidence interval expresses the statistical uncertainty around an estimated quantity under a specified method and assumptions. A narrower interval indicates greater precision for that estimate; a wider interval indicates less precision. It does not account automatically for biases in study design, missing observations, incomplete reporting, or misclassification. No confidence interval is reported in the registry entries for these adverse-event counts, and there is no comparative estimate to which an interval could be attached.

For a comparison between groups, statistical interpretation would also depend on how groups were formed and whether relevant differences were addressed. Random allocation can support a balanced comparison on average, whereas an observational surveillance group may differ from any external group in ways that affect outcomes. This record states that the study was not a randomized comparison and that allocation is not stated. It does not describe an adjustment strategy, an external comparator, or a model for estimating comparative effects. Therefore, general explanations of comparative tests or adjusted analyses should not be mistaken for methods used in this study.

Why can event counts vary in real-practice surveillance?

In general, observed counts depend on the population followed, the length and completeness of observation, the way events are elicited and recorded, and the definitions used to classify events. Longer observation can create more opportunity to observe an event, while incomplete follow-up can make the record less complete. The stated timeframe extends from baseline through 28 days after the last dose and up to 22 months. The registry does not report individual follow-up times, losses to follow-up, or the completeness of event ascertainment beyond defining the safety set as participants who completed follow-up.

General statistical methods may also need to account for over-dispersion when observed variability exceeds what a simple model assumes. That issue is relevant in some count-data analyses, but these posted primary results are participant counts, and the registry record does not report a model-based count analysis. No model assumptions, dispersion estimates, or adjusted analyses are reported. It would therefore be inappropriate to imply that a particular statistical model was used.

The registry includes a planning description based on a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and fractions of an observed effect; it distinguishes per-arm planning illustrations from total event counts for time-to-event planning. These are general planning assumptions, not a statement of the study's own design or an observed power calculation. Since the study is not described as a randomized two-arm comparison and no comparative effect estimate is included in the registry record, those planning assumptions do not provide evidence about the precision or power of the posted safety counts. The registry record does not report the study's sample-size justification.

Finally, the record reports nine outcome measures but no analyses. No multiplicity adjustment, missing-data method, interim analysis, statistical analysis plan, or hypothesis-testing procedure is reported. In general, multiple outcomes can raise questions about how results were selected and how false-positive findings are controlled, but the information is insufficient to determine whether or how those issues were addressed. Descriptive reporting of the listed counts remains distinct from an inferential claim about treatment effects.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures and reports no analyses. The registry entries do not identify a prespecified testing hierarchy, a primary-versus-secondary testing strategy beyond naming the primary outcome, or any adjustment for multiple comparisons. The registry record does not report interim analyses or a statistical analysis plan. As a result, the registry entries do not show whether formal hypothesis testing was planned or how multiplicity was handled.

In general, when multiple outcomes or comparisons are tested, the chance of at least one apparently notable result can increase if the tests are treated as independent opportunities for discovery. Methods for addressing this include prespecifying a testing order or adjusting inference, but no such approach should be attributed to this study without documentation. The reported adverse-event counts are descriptive and do not depend on an unreported multiplicity correction.

The safety analysis set is defined as participants who received Duavive at least once and completed follow-up. The registry separately lists enrollment of 669 and 639 at risk in the adverse-event summary. It does not report a participant-flow explanation, reasons for non-inclusion, missing outcome counts, or a missing-data method. General concerns include whether all eligible participants were followed for the same duration and whether event recording was complete; those details are not reported in the registry record. The record also does not explain how participants with incomplete follow-up, if any, were handled. These gaps limit assessment of completeness but do not establish that missing data occurred or that the results are biased.

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: meniere's disease (0.2%), breast cancer (0.2%).

The adverse-event summary lists 2 participants with serious adverse events and 71 with other adverse events among 639 participants at risk in the Duavive group. It reports 0 deaths. The serious-event terms listed are Meniere's disease and breast cancer, each recorded as 0.2%. These figures describe the registry's posted safety summary; the term percentages should be read as listed because further denominator details are not reported in the registry record.

The serious-event count is based on the registry's seriousness definition, which includes specified outcomes such as hospitalization, life-threatening experience, disability, congenital anomaly, and medically important events. The adverse-event definition does not require a causal relationship to treatment. Accordingly, neither the participant counts nor the listed terms demonstrate that Duavive caused the events. The record does not provide case narratives, event timing, or an attribution assessment for these results.

In general, safety counts are most informative when considered with the observation period, analysis population, and completeness of follow-up. The listed timeframe extends to 28 days after the last dose, for up to 22 months. The safety set excludes those who did not complete follow-up according to its definition, but reasons and missing-data details are not reported. With no randomized comparator described, these results do not quantify a comparative safety difference.

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

The registry record documents a completed post-marketing surveillance study of Duavive in real practice in Korea. Its primary safety outcome counts participants with adverse events and serious adverse events. The posted results list 639 participants at risk in the Duavive group, 2 participants with serious adverse events, 71 with other adverse events, and 0 deaths. The record also lists Meniere's disease and breast cancer among the top serious adverse-event terms, each at 0.2%.

These observations describe what was recorded for the group during the specified follow-up. They do not show that treatment caused the events, because the registry's adverse-event definition includes events without regard to possible causal relationship. They also do not establish a comparative effect: the study is not described as randomized, allocation is not stated, and no like-for-like control group is presented. The results cannot establish whether event counts would differ under a different treatment or without treatment.

The counts do not give a complete account of event severity, timing, duration, recurrence, or individual clinical circumstances. The record does not report those details, nor does it report confidence intervals or comparative estimates. The 0 deaths entry describes the reported result in this group and should not be interpreted as a guarantee that serious outcomes cannot occur.

In general, observational surveillance can contribute descriptive information about events recorded in routine practice, while causal conclusions require a design and analysis capable of supporting them. The record's stated purpose included evaluating safety and efficacy, but the registry entries available for interpretation give the primary safety outcome and selected adverse-event results, not a specific efficacy result. No conclusion about efficacy can be drawn from these safety counts. The registry record does not report the analysis plan, missing-data methods, or sample-size justification, which further limits what can be inferred about statistical precision and the intended analyses.

13. Why This Trial Matters Statistically

Post-marketing surveillance addresses a different statistical question from a randomized comparison. It records medical events among people receiving a treatment in real practice, potentially describing the kinds of events noted during follow-up. In this study, the registry identifies Duavive, real-practice use in Korea, and an adverse-event outcome extending from baseline to 28 days after the last dose, for up to 22 months. That context matters when deciding what the reported counts can and cannot establish.

The primary outcome is defined broadly: an adverse event need not be judged causally related to treatment to be counted. This is important statistically because a broad safety measure can capture events that occur during treatment without establishing why they occurred. The posted counts therefore serve as descriptive surveillance findings rather than direct estimates of treatment-attributable harm. The seriousness definition also helps distinguish events meeting specified medical criteria from other adverse events, while not resolving causality.

The record lists 2 participants with serious adverse events and 71 with other adverse events among 639 at risk, alongside 0 deaths. These figures make the reported safety observations explicit, but their interpretation depends on the analysis population and follow-up. The record defines the safety set as participants who received at least one tablet and completed follow-up, while separately listing 669 enrolled participants. The absence of a participant-flow account limits understanding of how those entries relate.

The study's nonrandomized status is equally important. A single monitored group can describe its recorded experience, but it cannot by itself distinguish treatment effects from other influences. The registry record does not report a comparator, allocation method, statistical analysis plan, or inferential estimates. Recognizing these limits helps keep descriptive safety evidence distinct from a causal or comparative claim, and prevents a simple event count from being mistaken for a complete evaluation of treatment effects.

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 record identifies the study as post-marketing surveillance and says it was not a randomized comparison. Allocation is not stated, and the adverse-event results describe a Duavive group without a like-for-like control group. This limits any comparative interpretation and does not support attributing observed events to treatment on the basis of the counts alone.

The registry reports 669 enrolled participants and 639 at risk in the adverse-event group. It defines the safety analysis set as people who received Duavive at least once and completed follow-up, but does not report a participant-flow account explaining the relationship between enrollment and the safety set. Reasons for non-inclusion, follow-up completion details, missing outcomes, and methods for handling missing data are not reported in the registry record.

The outcome definition is broad and includes adverse events regardless of possible causal relationship. The record does not report event-level case details, event timing, duration, repeat events, or how causality was assessed. The serious-event terms are listed with percentages, but further denominator details for those percentages are not reported. The registry entries also do not describe event ascertainment procedures or independent adjudication.

The registry reports nine outcome measures and no analyses. A statistical analysis plan, sample-size justification, interim analyses, multiplicity strategy, confidence intervals, and comparative estimates are not reported. The study's stated purpose includes efficacy, but no specific efficacy result is included in the registry record. These limitations constrain interpretation of statistical precision and prevent conclusions beyond the posted descriptive safety information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive — NCT02792504.
• Registry record last updated 2021-08-05; status last verified 2021-07.
• Results first posted 2021-08-05.
• 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

NCT02792504 is a completed post-marketing surveillance study titled “Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive.” Pfizer is named as sponsor. The study aimed to evaluate CE/BZA safety and efficacy in real practice in Korea among people with severe vasomotor symptoms associated with menopause. The registry lists 669 enrolled participants, a start date of 2016-03-29, and a primary completion date of 2020-07-22.

The primary outcome counts participants with adverse events and serious adverse events from baseline through 28 days after the last dose, for up to 22 months. The safety set is defined as participants who received at least one Duavive tablet and completed follow-up. The adverse-event summary lists 639 at risk, 2 with serious adverse events, 71 with other adverse events, and 0 deaths. Meniere's disease and breast cancer are listed as serious-event terms, each at 0.2%.

The study was not a randomized comparison; allocation is not stated. The registry lists nine outcome measures and no analyses. The analysis plan, sample-size justification, missing-data methods, and comparative efficacy results are not reported in the registry record.