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 Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis (NCT01622231), a na phase 3 study. The primary outcome is Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01622231 |
| Phase | Phase 3 |
| Condition | Rhinitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 61 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis. The primary safety outcome applies to the Safety Population, defined as all participants who received at least one dose of medication.
Intervention
GW685698X nasal spray, described as 55 μg/day once daily. The intervention is also identified as fluticasone furoate.
Comparator
There was no comparator group. The study is listed as single-group, with allocation recorded as not applicable and no masking.
Primary question
How many participants had any non-serious adverse event or any serious adverse event during the period from the start of study treatment through follow-up contact, up to 13 weeks?
The registry describes a safety-focused study of GW685698X in children with perennial allergic rhinitis. Its primary outcome is a participant count, rather than a comparison of outcomes between treatment groups. The posted result records 23 participants with a non-serious adverse event among 61 at risk, and no participants with a serious adverse event among 61 at risk.
The study also identifies efficacy and systemic exposure as secondary aims. Its listed secondary outcomes include changes in blood cell measures, hemoglobin, platelets, white blood cells, red blood cells, hematocrit, albumin, total protein, liver-related laboratory measures, bilirubin, and creatinine. Numerical results for those outcomes are not reported in the registry record. The study therefore addresses a descriptive safety question in a specific paediatric population; it does not, from the posted primary result, estimate a contrast against another treatment or control group.
3. Trial Design
This is a Phase 3, completed, open-label study with a single-group model. The registry lists allocation as not applicable and masking as none. A total of 61 participants were enrolled. All participants were intended to receive the study intervention, GW685698X nasal spray at 55 μg/day once daily; the arm description gives the dose as 55mcg/day. The intervention is identified as fluticasone furoate.
The study population was Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis. The registry describes safety assessment over 12 weeks, with efficacy and systemic exposure as secondary evaluation aims. The primary adverse-event outcome covers the period from the start of study treatment at Visit 2 until follow-up contact at Visit 6, up to 13 weeks. These descriptions identify the planned observation period, but do not establish that every participant completed the same duration of follow-up.
A single-group design can describe outcomes observed among people receiving the intervention, but it does not provide a concurrent control group for estimating a treatment contrast. The lack of masking also means the registry does not describe a blinded outcome assessment. These are design features, not evidence for or against an intervention effect. A protocol rationale for choosing the design, the criteria used to determine enrollment, and any sample-size justification are not reported in the registry record.
The study record lists 25 outcome measures, while no analysis records are listed. The primary outcome is the number of participants with any non-serious adverse event and any serious adverse event. Several secondary outcomes concern laboratory changes at Week 4 and Week 12 or early withdrawal. Numerical results for those secondary measures, and the methods used to analyze them, 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.
Before assignment: Participants who met the inclusion criteria at Visit 1/1A entered a Screening Period (Visit 1 to 2). Participants who met the eligibility criteria for randomization entered the Treatment Period (Visit 2 to 5), during which they received GW685698X 55 micrograms (µg) once daily (QD) for a period of 12 weeks.
Overall Study
| Stage | GW685698X 55 μg QD |
|---|---|
| STARTED | 61 |
| COMPLETED | 59 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | GW685698X 55 μg QD |
|---|---|
| Physician Decision | 1 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety Population: all participants who received at least one dose of medication
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | GW685698X 55 μg QD |
|---|---|---|
| Participants analysed | 61 | |
| Age, Continuous | Years | 8.0 (SD 3.59) |
| Gender: Female | Participants | 19 |
| Gender: Male | Participants | 42 |
| Race/Ethnicity, Customized: Asian - Japanese Heritage | participants | 61 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE), measured over From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with any non-serious adverse event and participants with any serious adverse event. It covers the interval from the start of study treatment at Visit 2 through follow-up contact at Visit 6, up to 13 weeks, and is defined for the Safety Population: all participants who received at least one dose of medication.
The registry defines an adverse event as an untoward medical occurrence temporally associated with use of a medicinal product, whether or not considered related to that product. It may include an unfavorable or unintended sign, including an abnormal laboratory finding, a symptom, or a new or exacerbated disease. A serious adverse event is defined by consequences such as death, a life-threatening event, hospitalization or prolonged hospitalization, disability or incapacity, a congenital anomaly or birth defect, another important medical event, or possible drug-induced liver injury.
Counting participants is useful for describing how many people in the safety population experienced events during the observation period. The posted result reports 23 participants with a non-serious adverse event and no participants with a serious adverse event, with 61 at risk in each category. These counts do not indicate whether an event was judged related to treatment, and they do not describe the number of separate events per participant. The registry refers readers to a general adverse-event module for a list of adverse events occurring at a frequency threshold of >=5% and serious adverse events; that list is not included in the posted primary result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary safety outcome is descriptive. Among 61 participants at risk, 23 were reported with any non-serious adverse event, and no participants were reported with any serious adverse event. The registry presents participant counts for one treated group. It does not present a concurrent untreated or active-comparator group, so the counts do not estimate a between-group difference.
The endpoint combines a broad range of possible medical occurrences under the adverse-event definition. An event is temporally associated with medicinal-product use, but the definition explicitly does not require that it be judged related to the medicinal product. The posted count therefore should not be read as a count of events attributed to GW685698X. The record does not report event-specific causal assessments in the primary result.
The serious-event count is zero among the 61 participants at risk during the stated observation window. This is a report of what was recorded in this study population and period, not evidence that serious events cannot occur. The registry does not report a confidence interval or another measure of uncertainty for this count. Without an uncertainty estimate, the precision of the result cannot be fully characterized from the posted numbers alone.
The non-serious-event count likewise describes the observed participants and follow-up, rather than a rate adjusted for time under observation. The record does not give person-time, participant-level follow-up completeness, or a breakdown of the 23 participants by event type in the primary result. It is therefore not possible to infer the timing, recurrence, severity distribution among non-serious events, or how many distinct events occurred from this count.
The study lists efficacy and systemic exposure among its secondary aims, but numerical findings for those aims are not reported in the registry record. The listed laboratory outcomes identify measurements intended for change-from-baseline assessment at Week 4 and Week 12 or early withdrawal. Their numerical changes and uncertainty are not reported in the registry record. No p-values, confidence intervals, or adjusted treatment estimates are listed, and no analysis records are listed. Consequently, the posted safety counts should be read as descriptive findings rather than as an inferential test or a comparative estimate.
In general, a confidence interval communicates the uncertainty around an estimated quantity under a specified statistical method. Its absence means the registry result does not show how much statistical uncertainty would accompany an estimate beyond the observed participant counts. That limitation is particularly relevant when interpreting a zero count: zero observed participants with an event does not establish a zero underlying possibility of such an event.
The record does not report the number of participants who discontinued, the amount of missing safety information, or the handling of incomplete follow-up. The enrollment total and the number at risk in the posted primary outcome are both 61, but those figures alone do not describe the completeness of every participant's observation period. Conclusions should therefore remain limited to the reported counts and the registry's stated population and timeframe.
9. Statistical Methods Explained
The primary endpoint is a participant count: people are classified according to whether they had any non-serious adverse event or any serious adverse event during the specified safety period. The record gives 61 participants at risk for each category. It reports 23 participants with any non-serious adverse event and no participants with any serious adverse event.
What does a participant count describe?
In general, a participant count summarizes how many people meet an outcome definition. For an outcome phrased as “any” event, a person is counted if at least one qualifying event occurs during the observation period. Such a count does not, by itself, convey the number of episodes, the time until an event, or the duration of an event. The registry's primary result is a count of affected participants, not a count of all event episodes.
The distinction between participant counts and event counts matters because one participant may experience more than one event. The primary result does not report how many separate events occurred among participants counted with an adverse event. Nor does it provide event-specific categories or timing in the primary outcome. Those details cannot be reconstructed from the participant totals.
Why does the design affect interpretation?
In general, a treatment comparison requires a contrast between outcomes under different assigned conditions or groups. This study is listed as single-group, with allocation not applicable and no masking. The posted result therefore describes outcomes among participants receiving GW685698X; it does not estimate how those outcomes compare with a control group's outcomes. An observed count in a single group cannot isolate the contribution of treatment from other influences on event occurrence.
The study is open-label. In general, lack of masking means participants and study personnel are not kept unaware of the assigned intervention. That design feature can be relevant to how events are noticed, reported, or assessed, especially for outcomes involving judgment. The registry record does not describe additional procedures used to reduce or assess any such influence, so the implications cannot be quantified from the posted information.
What uncertainty information is reported?
In general, a confidence interval gives a range of values that are compatible with an estimate under the assumptions of a statistical method. A p-value, when reported, addresses the compatibility of data with a specified null model; it is not a measure of clinical importance or the probability that a hypothesis is true. Neither a confidence interval nor a p-value for the primary safety counts is reported in the registry record. No analysis records are listed, so a formal inferential method for the posted counts is not described.
For a zero observed count, general statistical reasoning still recognizes uncertainty about the underlying event frequency. A study can observe no participants with an event while leaving open the possibility that the event could occur in a broader population or under different follow-up conditions. Because the registry does not report an interval estimate, readers should not treat the observed zero as a precise estimate of zero risk.
How should the planning assumptions be read?
In general, sample-size calculations ask how many participants or events may be needed for a planned comparison under stated assumptions. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe a planning illustration based on an observed effect and a stated fraction of that effect, not the documented design of this single-group study. The record does not report the trial's own sample-size justification.
The general distinction between a planning illustration and observed power is important. A calculation under hypothetical two-arm assumptions does not show the power achieved by a completed single-group study. The sample-size illustrations are not observed power estimates, and they do not convert the safety counts into a controlled treatment effect. In general, power is a property of a specified design and assumed effect, rather than a post hoc measure of whether a result is persuasive.
For a time-to-event endpoint, planning methods may work with event totals, whereas other designs may express sample size as participants per arm. Those general conventions do not change the interpretation of this endpoint, which is a participant count from a single group. The record does not provide a comparative endpoint or a randomized allocation to which a two-arm sample-size calculation could directly correspond.
What analyses can be assessed from the record?
The registry lists 25 outcome measures and no analysis records. This means the posted record does not describe statistical models, adjustment variables, hypothesis tests, or confidence-interval procedures for the outcome set. It is not possible to determine from the registry record whether analyses were prespecified in a separate protocol or reported elsewhere. No interim analysis plan is reported in the registry record.
In general, statistical models should reflect the outcome type and study design. A participant-level adverse-event indicator differs from a repeated event count, a continuous laboratory measurement, or a time-to-event outcome. The study's listed laboratory outcomes concern change from baseline, but the registry record does not report their numerical results or the analysis methods used. No model should be inferred from the outcome titles alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 25 outcome measures, including the primary adverse-event outcome and secondary measures covering laboratory changes, efficacy, and systemic exposure. No analysis records are listed. The registry record does not report how many outcomes were formally tested, whether a hierarchy of hypotheses was used, or whether any adjustment for multiple comparisons was planned or applied.
In general, testing many outcomes can increase the chance of finding at least one apparently unusual result by chance. Multiplicity procedures can address that issue, but their appropriateness depends on the aims and analysis plan. No such plan is reported in the registry record, so no conclusion can be drawn about how multiplicity was handled. The absence of analysis records also means there are no posted inferential results from which to assess the issue directly.
The Safety Population is defined as all participants who received at least one dose of medication. The primary outcome reports 61 at risk for each event category, matching the enrollment total of 61. The record does not report how missing observations, withdrawals, or incomplete follow-up were handled. It also does not report whether the listed secondary outcomes used the same analysis population.
In general, missing-data methods depend on why information is missing and on the outcome and analysis being considered. Without a description of follow-up completion, missingness, or an analysis approach, the effect of incomplete information cannot be evaluated from the registry record. The stated period extends from treatment start through follow-up contact, up to 13 weeks, but the record does not give individual follow-up durations or a missing-data sensitivity analysis.
Details of any prespecified analysis plan, interim analyses, or multiplicity strategy are not reported in the registry record. These omissions limit assessment of how the posted outcomes relate to planned statistical testing; they do not establish that such procedures were absent from other study documents.
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 |
|---|---|---|---|
| GW685698X 55 μg QD | 0 | 61 | 0.0% |
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 |
|---|---|
| GW685698X 55 μg QD | 23 of 61 |
Most frequent non-serious adverse event terms
| Event term | Organ system | GW685698X 55 μg QD |
|---|---|---|
| Nasopharyngitis | Infections and infestations | 15 of 61 |
| Acute sinusitis | Infections and infestations | 8 of 61 |
The posted serious adverse-event result is no participants with an SAE among 61 at risk. The non-serious adverse-event result is 23 participants among 61 at risk. These are participant counts for the period from the start of study treatment through follow-up contact, up to 13 weeks. They are not counts of every event episode and do not provide event rates per unit of follow-up time.
The registry's adverse-event definition is based on temporal association with use of a medicinal product, whether or not the event is considered related to that product. The counts therefore should not be interpreted as counts of events judged to have been caused by GW685698X. The primary result does not provide a detailed breakdown of the non-serious events. No serious adverse-event terms are listed in the record's serious-event terms field.
The deaths entry is not reported as a numerical count, so it should not be read as a reported zero. More generally, a zero observed serious-event count in this study does not show that serious events are impossible or establish the safety profile in populations beyond those observed. The registry does not report a confidence interval or a comparison group for these safety counts.
12. What the Result Does, and Does Not, Mean
The posted primary result describes adverse-event experience in a single group of Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis. Among 61 participants at risk, 23 had any non-serious adverse event, while no participants had any serious adverse event during the specified period. These numbers answer a descriptive question about observed participants; they do not establish a treatment effect.
Because the study has no comparator group, the counts cannot show whether the number of participants with events would have been different under another treatment or under no treatment. The adverse-event definition also includes events whether or not they are considered related to the medicinal product. The posted totals do not identify the causes of events, and they do not describe how many separate event episodes occurred.
The zero serious-event count is limited to the participants and follow-up captured in this study. It does not establish that serious events cannot occur, and no uncertainty interval is reported to show the precision of that observation. The deaths entry is not reported as a numerical count, so no conclusion about deaths should be drawn from that field.
The record identifies efficacy and systemic exposure as secondary aims, but numerical findings for those aims are not reported in the registry record. It also lists laboratory outcomes, without reporting numerical changes or inferential analyses. Consequently, the posted primary safety numbers do not support conclusions about efficacy, systemic exposure, or laboratory change.
In general, interpreting a clinical result requires considering the outcome definition, population, follow-up, study design, and uncertainty. Here, the registry reports the endpoint definition, the Safety Population, and the observation window, but it does not report confidence intervals, p-values, missing-data handling, or a comparative analysis. The meaning of the result should stay within those boundaries: it is a count-based description of reported adverse events in this study, not proof of causation, comparative safety, or broader outcomes.
13. Why This Trial Matters Statistically
This trial is statistically notable because its main result is a simple safety count in a single-group study. That structure makes the distinction between description and comparison especially important. The registry reports how many participants experienced events while receiving the intervention, but it does not contain a concurrent group that can serve as a basis for estimating a treatment contrast.
The primary outcome also illustrates why the unit of analysis matters. The endpoint counts participants with any qualifying event, not the total number of event episodes. A participant-level count can summarize how many people were affected, but it leaves unanswered questions about recurrence, timing, and event type. Those details require additional reporting that is not present in the primary result.
The study offers a defined safety population and observation period, which give the counts a clear context. At the same time, the absence of reported uncertainty estimates, analysis records, and missing-data methods restricts how precisely the result can be interpreted. The zero serious-event count is an observed finding, not an estimate demonstrating that the underlying possibility of such events is zero.
The registry lists a broad set of secondary outcomes, including laboratory measures, efficacy, and systemic exposure. Since numerical findings and analysis records are not listed, those outcomes cannot be evaluated statistically from the registry record. This distinction is useful when reading trial records: the presence of an outcome in a study description does not itself mean that numerical results or inferential analyses are available.
Overall, the record demonstrates how design, endpoint definition, and reporting determine what a statistic can answer. The safety counts describe observed participants over a stated period. They do not establish causation, comparative effects, or conclusions beyond the population and follow-up represented in the record.
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 single-group design is the central limitation for comparative interpretation. With no comparator group and allocation listed as not applicable, the registry result cannot estimate a difference in adverse-event outcomes between GW685698X and another condition. Open-label conduct also means masking was not used; the registry record does not describe any procedures to assess or mitigate possible effects on event reporting or assessment.
The primary endpoint is broad, counting participants with any non-serious or serious adverse event. The posted result does not include event-specific details for the 23 participants with non-serious events, the number of event episodes, their timing, or assessments of relatedness. The serious-event terms list is empty, and the deaths entry is not reported as a numerical count.
The registry does not report confidence intervals, p-values, or formal analysis records for the primary result. It also does not report participant-level follow-up completeness, withdrawals, missing-data methods, or sensitivity analyses. Although 61 participants were enrolled and 61 were listed at risk in each primary outcome category, those totals do not supply the missing details about individual observation periods.
The study's stated efficacy and systemic-exposure aims and its listed laboratory outcomes do not have numerical results in the registry record. The record also does not report a sample-size justification, a multiplicity plan, or an interim analysis plan. These reporting limitations prevent assessment of the precision and inferential status of outcomes beyond the posted safety counts. They do not establish what may have been documented in materials outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis — NCT01622231.
- Registry record last updated 2017-01-09; status last verified 2016-11.
- Results first posted 2013-08-12.
- 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 study was open-label and single-group, with 61 participants enrolled. It evaluated GW685698X, identified as fluticasone furoate, at 55 μg/day once daily in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis.
The primary outcome counted participants with adverse events from treatment start through follow-up contact, up to 13 weeks. In the Safety Population, 23 of 61 participants were reported with any non-serious adverse event, and no participants among 61 at risk were reported with any serious adverse event.
Efficacy and systemic exposure were secondary aims, and the record lists 25 outcome measures. Numerical secondary results and analysis records are not reported in the registry record. The primary counts are descriptive and do not provide a comparison with another group.