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 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis (NCT01794741), a randomized phase 3 study. The primary outcome is Adverse Events Report.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01794741 |
| Phase | Phase 3 |
| Condition | Allergic Rhinitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 405 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Meda Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 4 to 11 years with allergic rhinitis. The registry record lists total enrollment as 405, but does not describe the primary outcome population in its endpoint entry.
Intervention
Dymista nasal spray, described as azelastine 137mcg per spray and fluticasone propionate 50mcg per spray, one spray per nostril twice a day for three months.
Comparator
Fluticasone propionate nasal spray, described as 50mcg per spray per nostril twice a day. The arm description does not specify a treatment duration.
Primary question
How many treatment-emergent adverse events were reported during 3 months of treatment in each arm? The registry record posts event counts, but does not report an inferential comparison or an analysis estimate.
This is a safety comparison, not a reported assessment of symptom control or another measure of treatment benefit. The registry record identifies allergic rhinitis as the condition and lists one primary outcome measure, titled “Adverse Events Report.” Its description specifies reports of treatment-emergent adverse events, with the timeframe stated as 3 months of treatment.
The posted primary outcome counts are 124 events for Dymista and 37 for fluticasone propionate nasal spray. The outcome entry lists 302 participants for the Dymista arm and 98 for the fluticasone arm. These are the denominators attached to that outcome entry; the record does not explain how participants or events were counted, or whether participants could contribute more than one event.
The clinical question is therefore limited to what the registry reports about adverse-event counts. It cannot be expanded into a conclusion about comparative risk, because the record does not post a statistical comparison, uncertainty interval, or analysis population definition for this endpoint.
3. Trial Design
The registry record describes a randomized, parallel-group phase 3 trial with no masking. It is listed as completed, with enrollment of 405. The condition is allergic rhinitis, and the brief summary describes a 3 month safety study in children aged 4 to 11 years. The listed sponsor is Meda Pharmaceuticals.
Participants were assigned to Dymista nasal spray or fluticasone propionate nasal spray. The Dymista arm description specifies azelastine 137mcg per spray and fluticasone propionate 50mcg per spray, with one spray per nostril twice a day for three months. The comparator is described as fluticasone propionate 50mcg per spray per nostril twice a day. Its arm description does not state duration, although the primary outcome timeframe is 3 months of treatment.
Random allocation can help make treatment groups comparable at assignment, on average, but the record does not provide the randomization method, allocation concealment details, or a description of how assignment was implemented. With masking listed as none, the trial is open-label. The record does not explain whether outcome assessment was blinded or how adverse events were elicited and classified.
Enrollment is not identical to the arm-specific denominators attached to the posted primary outcome. Those outcome entries list 302 participants for Dymista and 98 for fluticasone propionate. The safety entries instead list 304 and 101 participants at risk, respectively. The reason for these different denominators is not reported in the registry record, so the counts should be interpreted using the denominator specific to each outcome entry.
The record lists one outcome measure and no posted analyses. It does not report the planned sample-size justification, a detailed statistical analysis plan, interim analyses, or a prespecified method for comparing the arms. Those details cannot be inferred from the phase, randomization, or enrollment 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.
Overall Study
| Stage | Dymista Nasal Spray | Fluticasone Propionate Nasal Spray |
|---|---|---|
| STARTED | 304 | 101 |
| COMPLETED | 285 | 92 |
| NOT COMPLETED | 19 | 9 |
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 | Dymista Nasal Spray | Fluticasone Propionate Nasal Spray | Total |
|---|---|---|---|---|
| Participants analysed | 304 | 101 | 405 | |
| Age, Categorical: <=18 years | Participants | 304 | 101 | 405 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 8.1 (SD 2.07) | 8.1 (SD 1.94) | 8.1 (SD 1.9) |
| Sex: Female, Male: Female | Participants | 121 | 49 | 170 |
| Sex: Female, Male: Male | Participants | 183 | 52 | 235 |
| Region of Enrollment: United States | participants | 304 | 101 | 405 |
6. Primary Endpoint
The registry lists the primary outcome as Adverse Events Report, measured over 3 months of treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | event |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Adverse Events Report.” It is recorded as a number of events, with the description specifying reports of treatment-emergent adverse events and a timeframe of 3 months of treatment. The posted values are 124 events in the Dymista arm and 37 in the fluticasone propionate nasal spray arm.
A count endpoint records how many events were reported, rather than directly stating how many participants experienced at least one event. A participant may have experienced no events, one event, or more than one event; the registry record does not explain its counting rules or say whether repeat events in one participant are counted separately. The reported number should therefore be read as an event count, not as a count of affected participants.
Safety endpoints are used to describe undesirable events observed during treatment and to support assessment of a treatment’s safety profile. Interpretation depends on the definitions, ascertainment procedures, observation time, and analysis population. These details are not fully described in the registry record. It gives a 3-month timeframe, but does not report event-level definitions, severity grading, attribution rules, or the method used to collect reports.
The entry lists 302 participants for Dymista and 98 for fluticasone propionate. Because these denominators do not turn an event count into a participant-level risk, a comparison of the counts alone cannot establish how the probability of experiencing an event differed between arms. No adjusted estimate, confidence interval, or statistical test for the primary endpoint is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a count of treatment-emergent adverse events during 3 months of treatment. The registry lists 124 events for Dymista and 37 for fluticasone propionate nasal spray. The corresponding outcome denominators are 302 and 98 participants. These are descriptive counts; the record does not report an inferential comparison between the arms.
The count is not the same as the number of participants who experienced an adverse event. Without a definition of how repeated events were counted, the number of participants with one or more events, or participant-level data, the reported totals do not establish how many individuals were affected. Nor do they specify event duration, severity, relationship to treatment, or whether a report was confirmed.
Denominators differ by outcome entry. The primary outcome lists 302 and 98 participants, while the separate safety entry lists 304 and 101 at risk. The registry record does not explain this discrepancy. These denominator sets should not be combined or treated as interchangeable. The total enrollment of 405 is a trial-level figure and is not a substitute for the population used in a particular outcome analysis.
The separate safety information reports serious adverse events in 1 participant at risk of 304 in the Dymista group and 0 participants at risk of 101 in the fluticasone propionate group. It also reports other adverse events in 114 of 304 and 25 of 101, respectively. These participant-level safety fields are distinct from the primary endpoint’s total event counts. The record does not explain the relationship between the two outcome formats, so they should be interpreted separately.
No estimate of the between-arm difference, confidence interval, p-value, or adjusted analysis is posted. In general, a confidence interval describes the precision of an estimate and the range of values compatible with the data under the method used. Without such an estimate, the precision of a comparative effect cannot be assessed from the registry result.
The trial is randomized, but randomization alone does not supply the missing details about analysis populations, event definitions, missing observations, or statistical methods. The record does not report these details. Consequently, the posted data support a description of recorded counts, not a definitive statistical conclusion about comparative safety.
The event counts should not be interpreted as evidence that one treatment is safer or less safe. The reported values depend on which events were captured and how they were counted, and the record does not provide enough information to reconstruct a participant-level comparison. The result is best read as a limited registry report of adverse-event totals and separate safety counts.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design and lists no masking. Randomization assigns participants to treatment groups by chance, which is intended to reduce systematic differences between groups at the start of a trial. It does not guarantee that groups will be identical, and it does not replace careful outcome definitions, complete follow-up, or an appropriate analysis. The registry record does not report the randomization procedure or allocation concealment details.
What does a count endpoint represent?
A count endpoint records the number of events observed, not necessarily the number of participants with an event. If a participant has repeated events, the total count can include each event, depending on the study’s counting rules. If the analysis instead counts only participants with at least one event, that is a different outcome. The registry record describes the endpoint as a number of treatment-emergent adverse events but does not state how repeat events were handled.
Counts may depend on how long participants are observed. A common general approach for unequal observation time is to relate event counts to person-time, but the registry does not report person-time or a rate analysis. It states a 3-month treatment timeframe. It also does not describe whether every participant contributed the full observation period.
Why do counts not directly compare risk?
A raw event total does not account for how many participants were observed, how long they were observed, or whether individuals contributed multiple events. A participant-level risk comparison would require a clearly defined outcome such as having at least one event, along with the number of participants in each analysis group. A count-rate comparison would require a defined exposure-time denominator and a suitable model. Neither comparative estimate is reported in the registry record.
Count outcomes can be analyzed using methods for discrete event data. In general, a Poisson model is one option when its assumptions fit the data. When variability in counts exceeds the model’s assumptions, over-dispersion can make standard errors too small if it is ignored; methods that allow extra variability may then be considered. These are general statistical considerations, not a description of the method used in this trial. The statistical method is not reported in the registry record.
What does uncertainty add?
An estimate describes the size and direction of a comparison, while a confidence interval communicates its precision under the stated analysis method. A p-value, when reported, addresses compatibility of the data with a specified null hypothesis under that method; it is not a measure of clinical importance. The registry record posts no comparative estimate, confidence interval, or p-value for the primary endpoint. It is therefore not possible to assess the precision of a treatment contrast from the posted result.
The event totals are descriptive. A descriptive difference between the displayed totals is not itself an adjusted or inferential treatment effect. No recalculated comparison is reported. Even a calculation from summary counts would require assumptions about the event-counting process and the independence or clustering of repeated events; those details are absent.
How should the different denominators be handled?
The primary outcome entry attaches denominators of 302 for Dymista and 98 for fluticasone propionate to its event totals. The separate safety entry lists 304 and 101 participants at risk. These denominator sets belong to different registry entries and are not explained as equivalent. The trial enrollment of 405 does not resolve the difference. Each result should be read with its own stated denominator, without substituting one set for the other.
For serious and other adverse events, the safety fields identify participants at risk and participants affected. These fields describe participant counts, unlike the primary endpoint’s total number of events. General interpretation of a participant-level count requires knowing how the safety categories were defined and whether follow-up was complete. The registry does not explain those details, nor does it report confidence intervals or comparative tests for these safety fields.
What can sample-size illustrations say?
Any sample-size illustrations associated with the posted results are planning illustrations based on the observed effect, not the trial’s actual design or a report of observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations describe hypothetical planning under those assumptions. They do not establish that the trial was designed to detect those effects, and they cannot replace a trial-specific sample-size justification. The trial’s own sample-size justification is not reported in the registry record.
The record lists zero posted analyses. It does not identify a model, test, adjustment strategy, or analysis population for the primary endpoint. Therefore, general statistical methods can clarify what information would be needed, but they cannot be attributed to this trial as methods actually used.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and no secondary outcome measures. It reports no posted analyses. A multiplicity adjustment addresses the increased chance of false-positive findings when multiple hypotheses or outcomes are tested. With no set of posted statistical tests or analysis plan, it is not possible to determine whether multiplicity was relevant or how it would have been handled. The protocol’s approach to multiplicity is not reported in the registry record.
The record does not state the primary endpoint’s analysis population, such as whether all randomized participants were included or whether the outcome was analyzed only among participants with available safety information. It also does not describe exclusions, withdrawals, missing observations, or the treatment of participants with incomplete follow-up. The primary outcome denominators differ from the denominators in the separate safety entry, and the reason is not reported in the registry record.
Missing data can affect interpretation when participants with unavailable outcomes differ from those with observed outcomes. In general, analysts need to describe the amount and reasons for missingness and the assumptions or methods used to address it. No missing-data strategy is reported. The registry record also does not specify whether participants were analyzed according to randomized assignment, treatment received, or another population definition.
These omissions limit assessment of possible selection bias and the robustness of the result. They do not demonstrate that data were missing or that a particular analysis was used; they mean those details are not reported in the registry record. The posted counts can be described as recorded, but their relationship to a prespecified analysis population cannot be established from the record.
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 |
|---|---|---|---|
| Dymista Nasal Spray | 1 | 304 | 0.3% |
| Fluticasone Propionate Nasal Spray | 0 | 101 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dymista Nasal Spray | 114 of 304 |
| Fluticasone Propionate Nasal Spray | 25 of 101 |
Most frequent serious adverse event terms
| Event term | Organ system | Dymista Nasal Spray | Fluticasone Propionate Nasal Spray |
|---|---|---|---|
| gastroenteritis elevated LFT | Gastrointestinal disorders | 1 of 304 | 0 of 101 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dymista Nasal Spray | Fluticasone Propionate Nasal Spray |
|---|---|---|---|
| epistaxis | Respiratory, thoracic and mediastinal disorders | 30 of 304 | 9 of 101 |
| headache | General disorders | 20 of 304 | 3 of 101 |
| cough | Respiratory, thoracic and mediastinal disorders | 11 of 304 | 3 of 101 |
| pyrexia | General disorders | 10 of 304 | 2 of 101 |
| otitis media | Ear and labyrinth disorders | 9 of 304 | 3 of 101 |
| vomiting | Gastrointestinal disorders | 9 of 304 | 2 of 101 |
| abdominal pain upper | Gastrointestinal disorders | 8 of 304 | 2 of 101 |
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 9 of 304 | 0 of 101 |
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | 8 of 304 | 1 of 101 |
Serious events with the highest arm-level rate: gastroenteritis elevated lft (0.3%).
The separate safety entry reports serious adverse events for participants at risk. In the Dymista group, 1 participant was affected among 304 at risk; in the fluticasone propionate nasal spray group, 0 participants were affected among 101 at risk. These are participant counts, distinct from the primary endpoint’s total event counts of 124 and 37.
The registry also reports other adverse events in 114 participants among 304 at risk with Dymista and 25 among 101 at risk with fluticasone propionate. A serious adverse event is a safety category, while “other” adverse events are reported separately in this record. The registry does not provide definitions or explain whether categories can overlap, so the categories should not be added together.
The listed serious term is “gastroenteritis elevated LFT” at 0.3%. The record does not clarify whether this wording represents a combined term or how it relates to the serious-event participant count. Death values are not reported in the registry record.
These figures are descriptive. The registry does not report a comparative estimate, uncertainty interval, or statistical test for serious events. With a small number of reported serious events, the counts alone provide limited information about comparative uncertainty. They should not be read as establishing a difference between treatments.
12. What the Result Does, and Does Not, Mean
The posted results document adverse events reported during a 3-month treatment timeframe in a randomized, open-label trial of children with allergic rhinitis. The primary outcome is expressed as event totals: 124 in the Dymista arm and 37 in the fluticasone propionate nasal spray arm. Its outcome entry lists 302 and 98 participants, respectively. Separate safety fields report participant counts for serious and other adverse events, using denominators of 304 and 101.
These are different kinds of measurements. An event total can include multiple events from one participant, whereas the safety fields identify participants affected. The registry does not explain the event-counting rules or why the denominators differ across entries. Keeping these measures separate is necessary to avoid treating event totals as participant risks or combining unlike counts.
The record does not report an analysis estimate comparing the treatment arms, a confidence interval, a p-value, or an adjustment for participant characteristics. It therefore does not show the precision of a comparative effect. The posted figures alone cannot establish whether any apparent difference in counts is attributable to treatment, chance, exposure time, event ascertainment, or other factors.
The trial’s randomized design is relevant to the planned comparison, but the registry does not provide enough information to evaluate the analysis in detail. The method of randomization, event definitions, analysis population, handling of missing data, and statistical plan are not reported. The absence of those details from the record is not evidence that they were absent from the trial conduct; it means they cannot be assessed from the registry record.
The results also do not address symptom improvement or establish comparative efficacy. The listed primary outcome concerns safety events, and no secondary outcome measures are posted. The responsible interpretation is limited to the recorded event and participant counts, with uncertainty about their definitions and analysis. No treatment recommendation or definitive safety ranking follows from these registry entries alone.
13. Why This Trial Matters Statistically
This trial illustrates why the form of an outcome matters as much as its numerical value. The primary endpoint is an event count, while the separate safety results report numbers of participants affected. Event totals and participant totals answer different questions. Confusing them can lead readers to interpret a count of repeated events as the number of people who experienced an event.
It also demonstrates why denominators must be tied to the result they accompany. The primary outcome entry lists 302 and 98 participants, whereas the safety entry lists 304 and 101 at risk. The registry does not explain the difference. Reporting a total enrollment figure alone would not resolve which population contributed to a specific outcome.
Open-label status is another relevant design feature for safety outcomes. In general, knowledge of treatment assignment can affect reporting, questioning, or classification of subjective events. That possibility does not show that reporting differed in this trial; the record does not describe ascertainment procedures or blinded assessment. It does make clear why those methods matter when interpreting adverse-event reports.
Finally, descriptive values are not a substitute for an uncertainty assessment. Without a comparative estimate and interval, readers cannot judge how precisely the trial distinguishes between possible treatment effects. The record’s lack of posted analyses also prevents evaluation of model choice, missing-data handling, or a prespecified analysis plan. These are not merely technical details: they define what conclusion the data can support.
The statistical lesson is to match the interpretation to the endpoint, denominator, and analysis actually reported. Here, the registry supports a description of recorded safety counts, but not a quantified or precise comparison of the treatments.
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 detail about the primary outcome. It identifies a count of treatment-emergent adverse events over 3 months of treatment, but does not define an event, describe how events were collected or classified, or explain whether repeated events in one participant were counted separately. It does not report severity grading, attribution to treatment, or event duration.
The denominators differ across outcome entries. The primary endpoint lists 302 participants for Dymista and 98 for fluticasone propionate; the safety entry lists 304 and 101 at risk. The record does not explain these differences or specify the analysis population. It also does not state how withdrawals, incomplete observation, or missing information were handled.
The trial was randomized and parallel-group, but the randomization procedure and allocation concealment are not described. Masking is listed as none, and the record does not explain whether adverse-event assessment was blinded or whether standardized questioning was used. These details could matter for how reports were elicited and categorized, but their influence cannot be determined from the record.
No statistical analyses are posted for the primary outcome. The registry does not report an effect estimate, confidence interval, hypothesis test, model, or adjustment strategy. The sample-size justification, interim analysis plan, and multiplicity approach are also not reported in the registry record. As a result, the precision and inferential strength of the comparison cannot be evaluated.
The separate serious-event information is also sparse. It lists participant counts and one serious term, but does not describe definitions, overlap among categories, or the relationship between that term and the serious-event count. Death values are not reported in the registry record. These limitations constrain interpretation to the descriptive information recorded, rather than a full comparative safety assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis — NCT01794741.
- Registry record last updated 2015-03-31; status last verified 2015-03.
- Results first posted 2015-03-31.
- 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.
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18. Record Summary
This completed phase 3 trial is listed as randomized, open-label, and parallel-group, with enrollment of 405 children with allergic rhinitis. It compared Dymista nasal spray with fluticasone propionate nasal spray. Dymista is described as azelastine 137mcg per spray and fluticasone propionate 50mcg per spray, one spray per nostril twice a day for three months. The comparator is described as fluticasone propionate 50mcg per spray per nostril twice a day.
The primary outcome is a count of treatment-emergent adverse events over 3 months of treatment. The posted counts are 124 for Dymista and 37 for fluticasone propionate, with outcome denominators of 302 and 98. Separate safety entries report serious adverse events in 1 of 304 and 0 of 101 participants, and other adverse events in 114 of 304 and 25 of 101 participants. The record does not explain the denominator differences.
No analyses are posted, and the registry record does not report a comparative estimate, confidence interval, or statistical test. The results are descriptive and do not establish the precision or direction of a comparative treatment effect.