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 A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1) (NCT01165424), a na phase 3 study. The primary outcome is Number of Participants With Adverse Events and Adverse Drug Reactions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01165424 |
| Phase | Phase 3 |
| Condition | Rhinitis, Allergic, Perennial |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
The study concerned children with perennial allergic rhinitis and assessed outcomes during treatment with mometasone furoate nasal spray. Its registry record describes treatment for 12 weeks, with an option to continue for up to 24 weeks when the subject or legal representative consented. The primary outcome was the number of participants with adverse events and adverse drug reactions from baseline to Week 24.
Population
Pediatric subjects 3-15 years old with perennial allergic rhinitis. The registry lists 80 enrolled participants and identifies the primary-outcome population as all treated participants.
Intervention
Mometasone furoate nasal spray, administered once daily. The described regimen was 100 μg/day for children 3 to 11 years and 200 μg/day for those 12 to 15 years.
Comparator
There was no comparator group. The study is described as single-group, with allocation listed as NA and masking listed as NONE.
Primary question
How many treated participants had adverse events or adverse drug reactions during the period from baseline to Week 24? The registry reports event counts but does not provide a controlled estimate of how these outcomes compare with another treatment or with no treatment.
This is therefore a descriptive safety question, not a randomized comparison of treatment strategies. The study also lists change from baseline in the total nasal symptom score as a secondary outcome, but the registry record does not provide a result for that outcome in the registry record reported for this analysis.
3. Trial Design
This was a Phase 3, multicenter, open-label study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis. The registry describes a single-group design, with no masking and no randomized allocation. Enrollment was 80. The primary-outcome population is identified as all treated participants, and the adverse-event results report 80 participants at risk.
The planned treatment period was 12 weeks, with treatment permitted to continue for up to 24 weeks if the subject or legal representative consented to continue. The stated dose was 100 to 200 μg/day, taken once daily. The regimen description specifies one spray per nostril for children 3 to 11 years old and two sprays per nostril for those 12 to 15 years old. Clinic visits included evaluation of adverse events, nasal symptom scores, and nasal findings. The description also states that serious adverse events and trial procedure-related adverse events would be reviewed 30 days after the end of follow-up.
Because there was no comparator group, the design can describe outcomes observed during the study but cannot by itself separate treatment-related effects from events that might also occur without treatment or under another treatment. Open-label conduct also means participants and study personnel were not masked to treatment. The registry record does not report additional information about the protocol’s sample-size justification, interim analyses, or statistical plan.
The study is marked completed. The registry record lists Organon and Co as the sponsor. The outcome details available for this analysis focus on adverse events; results for the secondary nasal symptom outcome are 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 | MFNS |
|---|---|
| STARTED | 80 |
| COMPLETED | 76 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | MFNS |
|---|---|
| Clinical adverse experiences | 1 |
| Laboratory adverse experiences | 1 |
| Did not meet entry criteria | 1 |
| Participant moved (relocated) | 1 |
Analysis population for the primary outcome, as defined in the registry: All treated participants
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 | MFNS |
|---|---|---|
| Participants analysed | 80 | |
| Age, Continuous | years | 9.2 (SD 3.4) |
| Sex: Female, Male: Female | Participants | 26 |
| Sex: Female, Male: Male | Participants | 54 |
| Region of Enrollment: Japan | Participants | 80 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events and Adverse Drug Reactions, measured over Baseline to Week 24.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events and adverse drug reactions, measured from baseline to Week 24. It is a count of participants who experienced an event, rather than a measure of event severity, duration, or frequency for each participant. The endpoint description identifies all treated participants as the population.
Counting participants with events is a straightforward way to describe how many people experienced reported harms during a defined observation period. This can be useful in a single-group study because it provides a direct account of events recorded among those treated. However, a count alone does not establish that treatment caused an event. That distinction is particularly important without a comparison group: the study does not show how often similar events would have occurred in comparable participants under a different condition.
The registry presents serious adverse events separately from other adverse events. It reports one participant with a serious adverse event among 80 at risk and 72 participants with other adverse events among 80 at risk. Inguinal hernia is listed among the top serious terms at 1.2%. A separate result for adverse drug reactions is not reported in the registry record, so the posted counts should not be read as a quantified estimate of drug-attributed reactions.
The stated endpoint window extends to Week 24, while treatment could continue for up to 24 weeks. The registry record does not provide further detail about how event onset, recurrence, or events after treatment discontinuation were handled in the endpoint calculation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results are descriptive. The registry reports one participant with a serious adverse event among 80 at risk, and lists inguinal hernia at 1.2% among the top serious terms. It also reports 72 participants with other adverse events among 80 at risk. These counts describe the experience recorded in the treated group over the stated observation period; they do not estimate a difference between treatments.
The serious-event count and the other-event count should be read as separate safety summaries. The registry does not provide event-level detail sufficient to determine how many events each participant experienced, how long events lasted, or whether events recurred. Nor does the record provide a separate numerical result for adverse drug reactions. As a result, the reported adverse-event counts cannot be treated as a measure of the number of events judged related to mometasone furoate.
The 1.2% figure is a registry-listed percentage for inguinal hernia among the top serious terms. It is not a comparison with an untreated group, nor does it indicate whether the condition was caused by treatment. The record also does not supply a comparative estimate, confidence interval, or hypothesis test for the safety outcomes. Those statistical summaries are not reported in the registry record.
Because the study used a single group, the observations do not distinguish events associated with treatment from background events or events related to other circumstances. Without randomization and a concurrent comparator, differences from an external population cannot be inferred from these results. The open-label design adds another interpretive consideration: reports and assessments were made without masking.
The denominator of 80 is reported for both serious and other adverse-event summaries. It does not establish that every participant had the same duration of observation. The registry describes treatment for 12 weeks and possible continuation for up to 24 weeks, but does not report how many participants continued beyond 12 weeks or their individual exposure times. The counts therefore should not be interpreted as exposure-adjusted rates.
No conclusion about the frequency of events under another treatment, or about the causal effect of treatment, can be drawn from this single-group summary. The appropriate reading is narrower: the registry records the stated numbers of participants with serious and other adverse events during the study, while several details needed for comparative or causal interpretation are not reported.
9. Statistical Methods Explained
The registry classifies the primary outcome as a count of participants with an event. This kind of outcome records whether a participant experienced an event within the specified follow-up window. It differs from a continuous outcome, such as a change in symptom score, and from an event-rate analysis that accounts for person-time. The primary endpoint is described from baseline to Week 24, and the analysis population is all treated participants.
What does a single-group result estimate?
In a single-group study, the observed count describes events in the participants who received the study treatment. There is no concurrent comparison group from which to estimate a treatment contrast. A treatment contrast would ask how outcomes differ between groups under their respective assigned conditions. Without that contrast, the event count is descriptive: it states what was recorded in the study group, not what would have occurred to the same participants under an alternative condition.
This distinction is important even when a count is reported with a denominator. The denominator identifies the number at risk in the registry summary, but it does not create a control condition. It also does not account for differences in follow-up duration unless the analysis explicitly models exposure time, and such an analysis is not reported in the registry record.
Why distinguish serious from other adverse events?
Serious adverse events and other adverse events are separate safety categories in the posted results. A serious event category helps readers identify events classified as serious, while the other-event summary captures events outside that category as reported. These categories answer different descriptive questions and should not be combined unless an explicit combined outcome is reported. No combined safety count is reported in the registry record.
The record lists one participant with a serious adverse event, 72 participants with other adverse events, and inguinal hernia at 1.2% among the top serious terms. These entries are not a complete account of event timing, severity gradations, recurrence, or attribution. A participant count also does not mean that only one event occurred: a participant may experience more than one event, and the registry summary does not provide the event-level information needed to describe that pattern.
What can a confidence interval add?
General statistical explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical model and sampling process. It can show a range of values reasonably compatible with the data and model, rather than presenting a point estimate as exact. For a single-group event count, an interval could describe uncertainty about the event frequency in a population represented by the study, subject to the assumptions used. It would not resolve the absence of a comparator or establish that treatment caused an event.
No confidence interval for the adverse-event results is reported in the registry record. The record also does not report a hypothesis test or adjusted estimate for these outcomes. Therefore, the results should not be described as statistically significant or nonsignificant.
How should the planning illustrations be read?
The sample-size illustrations are planning exercises computed from the observed effect, not the trial’s own design. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm for 80% power or other stated power levels. Time-to-event illustrations use total events.
These planning values, where displayed, are not observed outcomes and are not observed power for this completed single-group study. They describe hypothetical future planning under the stated assumptions. In particular, equal allocation between two arms does not change the design of this trial into a two-arm comparison. The registry record does not report the trial’s own sample-size justification, and the planning illustrations should not be mistaken for evidence that the trial was designed or powered to establish a safety difference.
What is not available for statistical review?
The registry record lists two outcome measures and no analyses. Detailed statistical methods for missing observations, event attribution, adjustment for multiple outcomes, and handling of differing follow-up durations are not reported in the registry record. Without those details, readers cannot assess whether additional analysis choices affected the reported counts. This absence of reported methods does not establish that no such procedures were used; it means that they cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures: the primary safety outcome and change from baseline in the total nasal symptom score. It lists no analyses. A multiplicity adjustment or a prespecified hierarchy for interpreting more than one outcome is not reported in the registry record. The presence of multiple outcomes does not, by itself, indicate that a particular adjustment was required or used; the relevant analysis plan is not available in the reported information.
Missing-data handling is also not reported in the registry record. The record does not state how participants without a Week 24 assessment were handled, whether outcome completion differed by duration of treatment, or whether any imputation method was used. It does not report how events occurring after discontinuation were treated for the primary outcome.
The primary-outcome population is identified as all treated participants. The adverse-event summaries use 80 participants at risk. No further analysis-population definition, exclusions, or participant flow details are reported in the registry record. The treatment description allows continuation beyond 12 weeks for up to 24 weeks, but the record does not report how many participants followed each duration or provide exposure-adjusted safety estimates.
These gaps limit evaluation of completeness and comparability of follow-up. They do not demonstrate that data were missing or that a particular analysis was inappropriate; they mean that the available record does not describe those aspects of the analysis.
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 |
|---|---|---|---|
| MFNS | 1 | 80 | 1.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MFNS | 72 of 80 |
Most frequent serious adverse event terms
| Event term | Organ system | MFNS |
|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | 1 of 80 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MFNS |
|---|---|---|
| Nasopharyngitis | Infections and infestations | 41 of 80 |
| Blood cortisol decreased | Investigations | 27 of 80 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24 of 80 |
| Pyrexia | General disorders | 13 of 80 |
| Pharyngitis | Infections and infestations | 11 of 80 |
| Bronchitis | Infections and infestations | 10 of 80 |
| Acute sinusitis | Infections and infestations | 9 of 80 |
| Cough | Respiratory, thoracic and mediastinal disorders | 8 of 80 |
| Acute tonsillitis | Infections and infestations | 7 of 80 |
| Abdominal pain | Gastrointestinal disorders | 6 of 80 |
Serious events with the highest arm-level rate: inguinal hernia (1.2%).
The registry reports one participant with a serious adverse event among 80 at risk. It lists inguinal hernia at 1.2% among the top serious terms. The same record reports 72 participants with other adverse events among 80 at risk. These are descriptive counts for the study group, not comparisons against a control group.
The serious-event count concerns participants, not necessarily the total number of serious events. The registry summary does not provide event-level detail about recurrence, timing, duration, or severity beyond the serious classification. The term and percentage for inguinal hernia should be read as a registry-listed serious-event term, not as evidence that the treatment caused that condition.
The record does not report a separate count for adverse drug reactions, so the overall adverse-event counts should not be interpreted as counts of events attributed to the drug. The death result is not reported in the registry record; its absence from the reported figures should not be read as a reported zero.
Follow-up could extend to 24 weeks, but the record does not provide individual exposure duration or an exposure-adjusted rate. As a result, the safest statistical reading is limited to the participant counts and term listed, without causal or comparative interpretation.
12. What the Result Does, and Does Not, Mean
The results establish what the registry reports for this treated group: one participant with a serious adverse event among 80 at risk, 72 participants with other adverse events among 80 at risk, and inguinal hernia at 1.2% among the top serious terms. They describe observations during a study in children with perennial allergic rhinitis receiving once-daily mometasone furoate nasal spray. The primary-outcome window is baseline to Week 24.
These observations do not establish how the event counts would compare under another treatment or without treatment. The study had no comparator group and was open-label, so its results cannot isolate the effect of treatment from background events or other influences. The registry does not report a separate numerical result for adverse drug reactions, and the listed event counts should not be treated as drug-attributed counts.
The figures also do not provide a full picture of exposure. Treatment was planned for 12 weeks, with possible continuation for up to 24 weeks, but individual treatment duration and exposure-adjusted results are not reported. Nor does the record provide event-level details such as recurrence or timing. These limitations mean the counts are best understood as the safety observations recorded in this study rather than as estimates that can be directly compared with results from another setting.
The study’s secondary outcome was change from baseline in total nasal symptom score, but that result is not reported in the registry record. No confidence interval, hypothesis test, or adjusted safety estimate is reported for the posted adverse-event results. The absence of these estimates means the precision of a broader population inference cannot be assessed from the record. It does not imply that an unreported effect is absent or that the observed counts are either reassuring or concerning in a comparative sense.
Overall, the registry supports a descriptive account of adverse events in the study group. It does not support a causal conclusion about treatment or a comparative conclusion about safety relative to another option.
13. Why This Trial Matters Statistically
This study illustrates a basic distinction in clinical-trial interpretation: an event count in a treated group is not the same as an estimate of a treatment effect. The registry gives counts for serious and other adverse events, but its single-group design has no concurrent comparison against which to judge whether those observations differ from what might otherwise have occurred.
The endpoint is also a participant count rather than an event rate adjusted for time under observation. That distinction matters because treatment could continue for 12 weeks or up to 24 weeks, and the registry record does not report each participant’s duration of exposure. A count with a denominator is useful descriptive information, but it does not account for variation in follow-up time.
The record further highlights why outcome labels and attribution should be kept separate. Adverse events are recorded during a study, whereas an adverse drug reaction implies an attribution to the drug. The registry’s primary outcome title includes both, but a separate numerical result for adverse drug reactions is not reported. Interpreting all recorded adverse events as drug-related would go beyond the information available.
Finally, the study lists a secondary symptom-score outcome but does not report its result in the information available for this analysis. No analyses are listed in the registry record. Together, these points show why design, outcome definition, follow-up, and reporting details are necessary to interpret trial results. The posted safety figures remain useful as a description of observed events, while their inferential scope is limited by the single-group design and the unreported analysis details.
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 most important limitation for interpretation is the absence of a comparator group. With a single-group, open-label design, the reported counts cannot estimate a difference in adverse-event frequency between treatment and another condition. They also cannot distinguish treatment-associated events from background events or other causes.
The registry record does not report individual follow-up duration, the number who continued beyond 12 weeks, or exposure-adjusted safety estimates. This matters because treatment could last up to 24 weeks, while the primary outcome window extends to Week 24. A participant count alone does not show how much observation time contributed to each participant’s result.
Event-level information is limited. The record reports participants with serious and other adverse events and lists inguinal hernia at 1.2% among the top serious terms, but it does not report details on timing, recurrence, duration, or individual event attribution. A separate adverse drug reaction result is not reported in the registry record. The death result is also not reported in the registry record.
Important analysis details are not reported, including missing-data methods, multiplicity handling, and statistical methods for the outcomes. The registry identifies all treated participants as the primary-outcome population but provides no additional analysis-population details. It lists a secondary total nasal symptom score outcome, but its result is not reported in the information available for this analysis.
These limitations restrict what can be concluded from the posted results. They do not establish that unreported methods were not used, that data were missing, or that an unreported outcome had a particular result.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1) — NCT01165424.
- Registry record last updated 2024-05-24; status last verified 2022-02.
- Results first posted 2012-01-23.
- 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
The registry describes a completed Phase 3, multicenter, open-label, single-group study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis. Enrollment was 80. The regimen was once daily at 100 to 200 μg/day, with treatment planned for 12 weeks and possible continuation for up to 24 weeks.
The primary outcome was the number of participants with adverse events and adverse drug reactions from baseline to Week 24, in all treated participants. The registry reports one participant with a serious adverse event among 80 at risk and 72 participants with other adverse events among 80 at risk. Inguinal hernia is listed at 1.2% among the top serious terms.
The study had no comparator group. A separate adverse drug reaction result, the secondary symptom-score result, confidence intervals, hypothesis tests, and additional analysis details are not reported in the registry record. The safety results therefore provide a descriptive account of events in the study group, not a controlled estimate of treatment effect.