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 to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219) (NCT01732458), a randomized phase 2 study. The primary outcome is Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01732458 |
| Phase | Phase 2 |
| Condition | Post-operative Nausea, Post-operative Vomiting |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 229 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned pediatric patients undergoing surgery, with prevention of post-operative nausea and vomiting as the clinical context. The registry record reports enrollment of 229 participants. It does not report the ages of participants or give further eligibility details in the information describing this trial. The primary pharmacokinetic assessment was intended to use samples collected around aprepitant dosing, with a flexible sparse sampling scheme to limit the burden of specimen collection in children.
Intervention
Participants in the aprepitant regimens received a single oral dose on Day 1, between 1 and 3 hours before expected induction of anesthesia. The three dose levels were described as equivalent to 125 mg, 40 mg, or 10 mg in adults. Participants in these regimens also received intravenous placebo for ondansetron immediately before anesthesia. The trial’s stated purpose included assessment of aprepitant pharmacokinetics, safety, and tolerability.
Comparator
The active comparator regimen was ondansetron administered intravenously immediately before induction of anesthesia, along with a matching oral placebo for aprepitant. The registry describes random allocation and an active-comparator-controlled design. It does not report the allocation ratio or give participant-level treatment assignments in the information summarized for this analysis. The three aprepitant dose groups and the ondansetron group are the regimens described in the record.
Primary question
The primary endpoint was intended to characterize aprepitant exposure, measured as the area under its plasma concentration-time curve from time 0 to infinity, after a single dose. This is a pharmacokinetic question, not a direct measure of nausea or vomiting. Although the record describes planned sampling and a model for AUC, it also states that the terminal elimination phase could not be assessed adequately because samples beyond 8 hours after dose were lacking. Derivation of AUC0-inf was therefore not possible. The registry record does not report a primary AUC result or a treatment comparison on that endpoint.
3. Trial Design
The registry identifies this as a Phase II study with randomized allocation and a parallel design. Its official title describes a Phase IIb, partially-blinded, randomized, active comparator-controlled study. The registry’s masking field says double masking, so the descriptions of masking are not fully aligned. The record does not explain the difference or specify which roles were masked. This makes it important not to infer more about masking procedures than the registry states.
The study enrolled 229 participants and is listed as completed. The recorded start date is 2013-02-12, and the primary completion date is 2016-09-26. The trial compared three single-dose aprepitant regimens with an ondansetron regimen. The aprepitant doses were described as equivalent to 125 mg, 40 mg, and 10 mg in adults. Aprepitant was given orally between 1 and 3 hours before expected induction of anesthesia; ondansetron was administered intravenously immediately before induction. Matching placebos accompanied the active treatments as described in the arm information.
The stated aims were to assess pharmacokinetics, safety, and tolerability in pediatric patients for prevention of post-operative nausea and vomiting. The primary endpoint concerned aprepitant exposure rather than a clinical measure of nausea or vomiting. The registry describes a flexible sparse sampling approach, with planned collection windows before and after administration. It also notes that full pharmacokinetic profiles using population pharmacokinetic modeling and simulation would be described in a separate report. That report is not included in the registry information summarized for this analysis.
The record does not report an allocation ratio, an age distribution, a sample-size justification, or detailed analysis populations. It also does not provide enough information to reconstruct all trial procedures or the complete statistical analysis plan. Randomization supports a treatment-group comparison in principle, but the intended primary pharmacokinetic quantity could not be derived according to the record. Thus, the design can be described, while the primary exposure result cannot be interpreted as a completed quantitative comparison.
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: Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses. Of remaining 228 randomized participants, 8 did not receive treatment.
Overall Study
| Stage | Aprepitant Dose 1: Equivalent to 125 mg in Adults | Aprepitant Dose 2: Equivalent to 40 mg in Adults | Aprepitant Dose 3: Equivalent to 10 mg in Adults | Ondansetron |
|---|---|---|---|---|
| STARTED | 60 | 58 | 58 | 52 |
| Treated | 57 | 55 | 56 | 52 |
| COMPLETED | 57 | 53 | 55 | 50 |
| NOT COMPLETED | 3 | 5 | 3 | 2 |
Reasons for not completing this period:
| Reason | Aprepitant Dose 1: Equivalent to 125 mg in Adults | Aprepitant Dose 2: Equivalent to 40 mg in Adults | Aprepitant Dose 3: Equivalent to 10 mg in Adults | Ondansetron |
|---|---|---|---|---|
| Lost to Follow-up | 0 | 2 | 0 | 0 |
| Non-Compliance With Study Drug | 0 | 0 | 1 | 0 |
| Physician Decision | 1 | 2 | 2 | 0 |
| Protocol Violation | 2 | 0 | 0 | 2 |
| Screen Failure | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.
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: All Participants as Treated (APaT) population; all randomized participants who received at least 1 dose of study treatment.
| Characteristic | Unit | Aprepitant Dose 1: Equivalent to 125 mg in Adults | Aprepitant Dose 2: Equivalent to 40 mg in Adults | Aprepitant Dose 3: Equivalent to 10 mg in Adults | Ondansetron | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 57 | 55 | 56 | 52 | 220 | |
| Age, Continuous | months | 90.4 (SD 64.3) | 87.5 (SD 64.6) | 85.1 (SD 59.7) | 86.0 (SD 65.0) | 87.3 (SD 63.0) |
| Age, Customized: Birth to <2 years | participants | 14 | 12 | 13 | 11 | 50 |
| Age, Customized: 2 years to <6 years | participants | 14 | 14 | 15 | 14 | 57 |
| Age, Customized: 6 years to <12 years | participants | 13 | 15 | 14 | 13 | 55 |
| Age, Customized: 12 years to 17 years | participants | 16 | 14 | 14 | 14 | 58 |
| Sex: Female, Male: Female | Participants | 23 | 19 | 28 | 16 | 86 |
| Sex: Female, Male: Male | Participants | 34 | 36 | 28 | 36 | 134 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose, measured over 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the area under the plasma concentration-time curve of aprepitant from time 0 to infinity, abbreviated AUC0-inf. In general, an area under a concentration-time curve represents drug exposure over time: it incorporates measured concentrations and the way concentration changes across the observation period. Extending the curve to infinity requires an estimate of the terminal elimination phase, which describes how concentrations decline after the measured sampling period.
Exposure measures are used in pharmacokinetic research to characterize how much drug reaches the circulation over time. In this study, the planned endpoint was to be assessed after a single dose, with age considered in the planned model at each dose level. Such information can be relevant when characterizing dosing in a pediatric population, but it is not itself a measure of whether nausea or vomiting occurred or was prevented.
The registry describes sampling at 30-60 minutes before administration, 2-4 hours after administration, 5-7 hours after administration, and 8-10 hours after administration. It also explains that the opportunity for specimen collection in children was limited and that flexible time windows were planned to reduce participant burden. However, the record states that samples beyond 8 hours after dose were lacking, limiting assessment of the terminal elimination phase. Because AUC0-inf depends on that phase, the registry says derivation of the endpoint was not possible. No AUC estimate or corresponding uncertainty is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry names a pharmacokinetic endpoint but reports that it could not be derived. The planned primary measure was aprepitant AUC0-inf after a single dose. The record attributes the limitation to the lack of samples beyond 8 hours after dose, which prevented adequate assessment of the terminal elimination phase and made parameters dependent on lambda, including AUC0-inf, unavailable. Consequently, the posted information does not establish an estimated AUC for any dose group or a comparison of exposure between groups.
The study’s clinical context was prevention of post-operative nausea and vomiting, but the primary endpoint is drug exposure rather than a clinical outcome. The registry information does not provide a nausea or vomiting result for a single primary comparison. The listed outcome-measure and analysis counts do not replace an endpoint estimate, and the record does not give a numerical primary result, confidence interval, or p-value for AUC0-inf. Without those results, the magnitude and precision of any primary exposure effect cannot be evaluated.
The adverse-event information is descriptive. Serious adverse events were reported for 0 participants in the Aprepitant 125 mg Adult Equivalent group, 6 in the Aprepitant 40 mg Adult Equivalent group, 1 in the Aprepitant 10 mg Adult Equivalent group, and 2 in the Ondansetron group. The registry also lists participants with other adverse events: 11, 11, 12, and 16, respectively. These counts should be read as recorded group summaries, not as evidence of a causal treatment effect. The record does not provide a statistical comparison, adjustment, or uncertainty interval for these summaries.
Several serious-event terms are listed with percentages, including post procedural haemorrhage at 5.5%, procedural complication at 1.9%, male genital tract fistula at 1.9%, cardio-respiratory arrest at 1.8%, bladder perforation at 1.8%, and pulmonary oedema at 1.8%. The registry information does not specify the denominators or explain how these terms relate to the treatment groups, so the percentages should not be used to calculate comparative risks. Death counts are not reported in the registry record. Overall, the posted results support description of the study design and reported event counts, but do not support a quantitative conclusion about the primary pharmacokinetic endpoint or comparative clinical efficacy.
9. Statistical Methods Explained
The record describes a planned pharmacokinetic analysis of aprepitant concentrations. Pharmacokinetics concerns how drug concentrations change in the body over time. AUC is a summary of exposure across a specified time interval. For AUC0-inf, the interval extends from time 0 to infinity, so the observed concentration data alone are not enough: the unobserved tail of the concentration curve must be characterized or estimated. The registry states that missing samples beyond 8 hours after dose limited assessment of the terminal elimination phase and prevented derivation of AUC0-inf. This is a limitation of the endpoint information, not evidence that a particular AUC value was zero or that the groups had identical exposure.
The planned collection schedule used flexible windows: 30-60 minutes before administration, 2-4 hours after administration, 5-7 hours after administration, and 8-10 hours after administration. The record says sparse sampling was selected because specimen collection opportunities in children were limited and the approach was intended to reduce participant burden. Sparse sampling can be useful when dense sampling is impractical, but it places greater importance on the assumptions and model used to interpret the available concentration data. General explanation: when observation does not cover the full concentration-time profile, estimation of later drug elimination depends on whether the observed data and modeling approach adequately represent that unobserved period. The registry’s stated lack of samples beyond 8 hours is why the terminal phase and AUC0-inf were not available in this analysis.
The endpoint description says AUC0-inf data were to be log transformed and analyzed with a linear mixed-effects model containing fixed effects for age for each dose level tested. General explanation: a logarithmic transformation can make a skewed positive measurement more suitable for a model whose assumptions concern residual distributions and variance. A fixed effect represents a modeled, systematic contribution of a specified predictor. A mixed-effects model can also account for structured variation in the data, although the registry excerpt does not identify the full set of model terms, any random effects, covariance structure, or diagnostic checks. It is not possible to determine from the record whether the planned model was fitted, what estimates it produced, or how the age effects were represented in the final analysis.
General explanation: a confidence interval expresses uncertainty around an estimated quantity under the analysis assumptions. A p-value addresses compatibility between data and a specified null hypothesis, also under assumptions. Neither can substitute for the effect estimate itself, and neither is reported for the primary AUC endpoint in the registry information. Since the endpoint could not be derived, there is no posted AUC estimate to pair with a confidence interval or significance test. The record does not report an alternative primary pharmacokinetic estimate that would resolve that gap.
The trial is described as randomized, parallel, and active comparator-controlled. Randomization is intended to reduce systematic differences between treatment groups at baseline, on average, when assignment is implemented as planned. It does not ensure that every characteristic is balanced, nor does it address missing endpoint information by itself. An active comparator is a treatment used as a control rather than an inactive control; in this study, the comparator regimen was ondansetron. The registry’s official title calls the study partially blinded, while its masking field reports double masking. The exact masking procedures and the reason for this difference are not reported in the registry record.
Safety counts are not equivalent to an inferential comparison. General explanation: counts describe observed events, while a comparative analysis would require a defined estimand, an approach to denominators and follow-up, and suitable uncertainty estimates. The registry reports group counts for serious and other adverse events, but the information does not give a statistical test or adjusted comparison for those counts. The terms and percentages listed for serious events also lack denominator detail in the record. They therefore describe what was recorded without establishing whether observed differences are due to treatment, chance, underlying clinical differences, or other factors.
The registry gives sample-size assumptions for planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such planning calculations are hypothetical illustrations of sample size under assumptions; they are not observed power and do not show that the trial was designed around those assumptions. The registry does not report the trial’s own sample-size justification. The primary outcome was not reduced to a single comparison for these calculations, so no specific planning result for the primary endpoint should be inferred from the posted information.
Another pharmacokinetic report using population pharmacokinetic modeling and simulation was described as separate. Its results are not reported in the registry record. General explanation: a population model can use data across participants to characterize typical concentration patterns and variation between participants, but the model’s usefulness depends on the data, assumptions, and validation. No such model estimates or validation findings can be attributed to this registry information.
10. Multiplicity, Missing Data and Analysis Populations
The registry record describes 41 outcome measures and 3 analyses, but does not report a multiplicity adjustment or a hierarchy for interpreting multiple outcomes. Multiplicity arises when several outcomes, groups, time points, or statistical tests are examined: even if each test is considered separately, the chance of at least one apparently unusual result can increase. General explanation: a prespecified testing strategy can control how evidence is interpreted across related comparisons. The registry information does not give enough detail to determine whether such a strategy was used in the final analyses.
The primary endpoint itself was not available as a derived AUC0-inf result. The record states that the terminal elimination phase could not be assessed because samples beyond 8 hours after dose were lacking. This is different from an ordinary missing value for a participant whose endpoint could otherwise be calculated: the stated limitation concerns whether the endpoint parameter could be derived from the sampling information. The registry does not report how many participants had usable concentration samples at each time window or whether any alternative endpoint was analyzed.
The record does not report analysis populations, exclusions, imputation methods, sensitivity analyses, or a detailed account of missing data. It therefore does not permit assessment of whether the analyses followed an intention-to-treat, per-protocol, or pharmacokinetic-evaluable population definition. Such labels should not be inferred from randomization alone. The planned sparse sampling scheme was described as a way to limit participant burden, but the registry does not explain whether all planned samples were collected or how departures from scheduled sampling were handled.
For adverse events, the registry reports group counts but does not provide inferential comparisons or uncertainty estimates. The denominator context for the listed serious-event percentages is also not reported in the registry record. As a result, the event summaries can be described, but they cannot establish a multiplicity-adjusted safety conclusion or a comparative effect.
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 |
|---|---|---|---|
| Aprepitant 125 mg Adult Equivalent (Dose 1) | 0 | 57 | 0.0% |
| Aprepitant 40 mg Adult Equivalent (Dose 2) | 6 | 55 | 10.9% |
| Aprepitant 10 mg Adult Equivalent (Dose 3) | 1 | 56 | 1.8% |
| Ondansetron | 2 | 52 | 3.8% |
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 |
|---|---|
| Aprepitant 125 mg Adult Equivalent (Dose 1) | 11 of 57 |
| Aprepitant 40 mg Adult Equivalent (Dose 2) | 11 of 55 |
| Aprepitant 10 mg Adult Equivalent (Dose 3) | 12 of 56 |
| Ondansetron | 16 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Aprepitant 125 mg Adult Equivalent (Dose 1) | Aprepitant 40 mg Adult Equivalent (Dose 2) | Aprepitant 10 mg Adult Equivalent (Dose 3) | Ondansetron |
|---|---|---|---|---|---|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 0 of 57 | 3 of 55 | 0 of 56 | 0 of 52 |
| Cardio-respiratory arrest | Cardiac disorders | 0 of 57 | 1 of 55 | 0 of 56 | 0 of 52 |
| Bronchiolitis | Infections and infestations | 0 of 57 | 0 of 55 | 1 of 56 | 0 of 52 |
| Procedural complication | Injury, poisoning and procedural complications | 0 of 57 | 0 of 55 | 0 of 56 | 1 of 52 |
| Bladder perforation | Renal and urinary disorders | 0 of 57 | 1 of 55 | 0 of 56 | 0 of 52 |
| Male genital tract fistula | Reproductive system and breast disorders | 0 of 57 | 0 of 55 | 0 of 56 | 1 of 52 |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 0 of 57 | 1 of 55 | 0 of 56 | 0 of 52 |
| Thrombosis | Vascular disorders | 0 of 57 | 1 of 55 | 0 of 56 | 0 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Aprepitant 125 mg Adult Equivalent (Dose 1) | Aprepitant 40 mg Adult Equivalent (Dose 2) | Aprepitant 10 mg Adult Equivalent (Dose 3) | Ondansetron |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | 4 of 57 | 4 of 55 | 3 of 56 | 5 of 52 |
| Abdominal pain | Gastrointestinal disorders | 3 of 57 | 3 of 55 | 4 of 56 | 4 of 52 |
| Vomiting | Gastrointestinal disorders | 2 of 57 | 3 of 55 | 2 of 56 | 4 of 52 |
| Pyrexia | General disorders | 3 of 57 | 1 of 55 | 3 of 56 | 0 of 52 |
| Accidental overdose | Injury, poisoning and procedural complications | 0 of 57 | 0 of 55 | 1 of 56 | 3 of 52 |
Serious events with the highest arm-level rate: post procedural haemorrhage (5.5%), procedural complication (1.9%), male genital tract fistula (1.9%), cardio-respiratory arrest (1.8%), bladder perforation (1.8%).
The registry lists serious adverse-event counts by treatment group. The Aprepitant 125 mg Adult Equivalent group had 0 participants with a serious adverse event among 57 at risk; the Aprepitant 40 mg Adult Equivalent group had 6 among 55; the Aprepitant 10 mg Adult Equivalent group had 1 among 56; and the Ondansetron group had 2 among 52. The record also lists participants with other adverse events as 11 among 57, 11 among 55, 12 among 56, and 16 among 52, respectively.
These are descriptive group summaries. They do not by themselves show that one regimen caused more or fewer events than another. The registry record does not report a statistical comparison, confidence intervals, or details needed to interpret differences in follow-up or event ascertainment. Counts of participants with events should also not be mistaken for counts of event episodes.
The registry lists serious-event terms with percentages: post procedural haemorrhage, 5.5%; procedural complication, 1.9%; male genital tract fistula, 1.9%; cardio-respiratory arrest, 1.8%; bladder perforation, 1.8%; and pulmonary oedema, 1.8%. The denominator and treatment-group context for these percentages are not reported in the registry record. Death counts are also not reported in the registry record; their absence should not be read as a reported zero.
12. What the Result Does, and Does Not, Mean
The registry record supports a clear description of the trial’s question and design: pediatric patients were assigned to aprepitant dose regimens or an ondansetron comparator in a study of pharmacokinetics, safety, and tolerability related to prevention of post-operative nausea and vomiting. The stated primary pharmacokinetic measure was AUC0-inf after a single dose. However, the record also states that the terminal elimination phase was inadequately assessed because samples beyond 8 hours after dose were lacking, and that AUC0-inf could not be derived.
This means the posted information does not provide a numerical estimate of aprepitant exposure for the primary endpoint. It also does not provide a primary AUC comparison, an uncertainty interval, or a significance test. The registry therefore cannot establish the size or precision of a dose-related exposure pattern from the stated endpoint. Nor can a pharmacokinetic endpoint by itself establish whether post-operative nausea or vomiting was prevented. The record does not give a single clinical outcome comparison that can be interpreted as evidence of benefit or lack of benefit.
The adverse-event counts and listed serious-event terms provide descriptive safety information. They do not establish comparative safety, since no statistical comparison or uncertainty estimates are reported and some context for the listed percentages is absent. The reported counts should not be converted into claims about causation. Similarly, missing death counts are not equivalent to a report of no deaths.
General interpretation: a randomized design can strengthen the basis for comparing groups when the relevant outcomes are measured and analyzed as planned. Randomization cannot compensate for an endpoint that is not estimable from the available sampling. The registry notes that complete pharmacokinetic profiles using population pharmacokinetic modeling and simulation would be described in a separate report, but those results are not reported in the registry record. Any conclusion about that separate analysis would require its actual estimates and methods.
The appropriate scope of interpretation is therefore limited. The record establishes that the study was completed and describes its regimens, planned pharmacokinetic assessment, sampling limitation, and adverse-event summaries. It does not provide a quantitative primary exposure result or a basis for concluding that aprepitant did or did not prevent nausea or vomiting. Absence of a reported endpoint estimate is not evidence of no effect; it is a constraint on what can be inferred from this record.
13. Why This Trial Matters Statistically
This trial is statistically informative because it illustrates the difference between a planned endpoint and an estimable endpoint. AUC0-inf was selected to characterize aprepitant exposure over time, but it depends on information about the terminal elimination phase. The registry states that samples beyond 8 hours after dose were lacking and that AUC0-inf could not be derived. A clearly defined endpoint is not sufficient on its own: the sampling schedule must also support its estimation.
The study also illustrates a practical challenge in pediatric pharmacokinetic research. The registry describes sparse sampling as a way to accommodate limited specimen-collection opportunities and reduce participant burden. General explanation: sparse sampling can help make research feasible, but model-based estimation then relies on assumptions about concentration patterns and how observations from participants combine. For an endpoint that extends beyond observed sampling, the adequacy of information about the terminal phase becomes especially important. The record identifies this specific limitation rather than reporting a completed exposure estimate.
Another statistical distinction is between pharmacokinetic outcomes and clinical outcomes. Drug exposure can help characterize the concentration-time profile, but it is not interchangeable with a direct measure of nausea or vomiting. The study’s clinical purpose concerned prevention of post-operative nausea and vomiting, while the stated primary endpoint was AUC0-inf. The registry information does not provide a single clinical comparison that can answer the prevention question statistically.
Finally, descriptive safety counts and percentages should be distinguished from comparative evidence. The registry gives counts by regimen, but does not report uncertainty intervals or inferential comparisons, and the denominator context for the serious-event percentages is not reported. Reading these results with attention to endpoint estimability, measurement, and the limits of descriptive summaries helps keep conclusions aligned with what the record actually documents.
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 main trial-specific limitation is that the planned primary AUC0-inf endpoint could not be derived. The registry attributes this to a lack of samples beyond 8 hours after dose, which limited assessment of the terminal elimination phase. Since AUC0-inf depends on that phase, the record does not provide a primary exposure estimate or treatment comparison.
The planned sampling windows were flexible and sparse, reflecting limited opportunities for specimen collection in children. The registry does not report the number of samples collected at each window, deviations from planned timing, or whether concentration data were available for every participant. It also does not give an alternative primary pharmacokinetic endpoint in place of AUC0-inf.
The information summarized in the registry does not report a detailed sample-size justification, allocation ratio, analysis populations, missing-data approach, sensitivity analyses, or multiplicity strategy. It also does not provide a full statistical analysis plan or the output of the planned linear mixed-effects model. The record describes age as a fixed effect for each dose level in the planned AUC analysis, but does not report fitted estimates or model diagnostics.
The registry’s masking descriptions differ: the official title says partially blinded, while the masking field says double. The reason and operational details are not reported. For safety, serious-event counts are available by group, but the record does not include inferential comparisons or uncertainty estimates. The denominator context for the listed serious-event percentages is not reported, and death counts are not reported in the registry record. These limits constrain interpretation of both the primary pharmacokinetic question and the descriptive safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219) — NCT01732458.
- Registry record last updated 2018-09-25; status last verified 2018-08.
- Results first posted 2017-09-06.
- 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 NCT01732458 as a completed randomized, parallel, active comparator-controlled Phase II study in pediatric patients. Enrollment was 229. The trial compared three single-dose aprepitant regimens, described as equivalent to 125 mg, 40 mg, or 10 mg in adults, with intravenous ondansetron. The stated aims concerned aprepitant pharmacokinetics, safety, and tolerability for prevention of post-operative nausea and vomiting.
The primary endpoint was planned as aprepitant AUC0-inf. The registry states that the terminal elimination phase could not be assessed adequately because samples beyond 8 hours after dose were lacking, so AUC0-inf could not be derived. The record reports descriptive adverse-event counts by group but does not report a primary AUC estimate, a comparative clinical outcome result, or statistical safety comparisons. It also describes separate population pharmacokinetic modeling and simulation reporting, whose results are not reported in the registry record.