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 Prasugrel in Pediatric Participants With Sickle Cell Disease (NCT01476696), a non-randomized phase 2 study. The primary outcome is Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01476696 |
| Phase | Phase 2 |
| Condition | Sickle Cell Disease |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Pediatric participants with sickle cell disease who received prasugrel. The primary endpoint population is described as participants who received at least 1 dose. The registry records enrollment of 33, but does not report an age range or further eligibility details in the registry record for this analysis.
Intervention
Oral prasugrel, evaluated in a dose-ranging study with a single-dose part and a once-daily dosing part. Part A doses ranged from 0.03 to 0.60 mg/kg, with doses titrated up or down based on desired platelet inhibition. Part B used doses expected to achieve mean platelet activation inhibition of 30% and 50%.
Comparator
There was no randomized comparator arm. The study is recorded as nonrandomized and single group, with no masking. Dose levels and study parts describe the dosing evaluation; they should not be treated as randomized, like-for-like treatment and control groups.
Primary question
How does prasugrel active-metabolite exposure, measured as AUC from time 0 to the last sampling time of 4 hours postdose, vary across the recorded doses and study parts? The endpoint is pharmacokinetic rather than a direct measure of clinical benefit. Numerical primary-endpoint results are not reported in the registry record.
3. Trial Design
This phase 2 study evaluated prasugrel in pediatric participants with sickle cell disease. The record describes it as open-label, nonrandomized, and single group, with no masking. Its stated purpose was to determine an appropriate prasugrel dosage for children with sickle cell disease. Enrollment is recorded as 33. The study status is completed, with a start date of 2011-11 and primary completion recorded as 2012-11.
The study had two dosing parts. Part A was a single-dose range-finding phase. Participants received oral prasugrel as an oral-disintegrating tablet, with doses from 0.03 to 0.60 mg/kg titrated up or down based on desired platelet inhibition. A single dose could be given up to 3 occasions, at different strengths, with up to 18 days between doses. The registry lists the dose levels used for the primary pharmacokinetic endpoint from 0.03 through 0.6 mg/kg.
Part B evaluated once-daily dosing. The stated sequence was a dose expected to achieve mean platelet activation inhibition of 30%, administered once daily for 10-18 days, followed by a dose expected to achieve mean platelet activation inhibition of 50%. The duration for the latter dosing period is not reported in the registry record. The primary endpoint description identifies on-site doses of 0.06, 0.08, and 0.12 mg/kg for Part B.
These design features support description of exposure across dose levels, but they do not establish a randomized comparison between groups. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected. The registry does not report a control group, masking, or a statistical analysis plan.
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: The study was conducted in 2 parts: Part A (single-dose range finding phase) then Part B (once-daily repeated dosing phase). Participants completing Part A could, but were not required to, participate in Part B. There were 2 dosing periods during Part B of the study.
Overall Study
| Stage | Part A: Prasugrel Single Dose | Part B: Prasugrel Once-Daily Dose | Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose |
|---|---|---|---|
| STARTED | 15 | 9 | 9 |
| Received at Least 1 Dose of Study Drug | 15 | 9 | 9 |
| COMPLETED | 12 | 8 | 9 |
| NOT COMPLETED | 3 | 1 | 0 |
Reasons for not completing this period:
| Reason | Part A: Prasugrel Single Dose | Part B: Prasugrel Once-Daily Dose | Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose |
|---|---|---|---|
| Sponsor decision | 2 | 1 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants who received at least 1 dose of prasugrel.
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 enrolled participants.
| Characteristic | Unit | Entire Study Population |
|---|---|---|
| Participants analysed | 33 | |
| Age, Customized: ≥2 and ≤5 years | participants | 7 |
| Age, Customized: ≥6 and ≤11 years | participants | 14 |
| Age, Customized: ≥12 and ≤17 years | participants | 12 |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 14 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 32 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 1 |
| Race/Ethnicity, Customized: Black or African American | participants | 32 |
| Region of Enrollment: United States | participants | 33 |
| Height | centimeters (cm) | 139.21 (SD 22.663) |
| Weight | kilograms (kg) | 38.55 (SD 18.785) |
| Body Mass Index | kilograms per square meter (kg/m^2) | 18.64 (SD 4.091) |
| Genotype: HbSS | participants | 30 |
| Genotype: HbS Beta^0 Thalassemia | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM), measured over Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanograms*hour per milliliter (ng*hr/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the concentration-time curve for prasugrel active metabolite, abbreviated Pras-AM, from time 0 to the last sampling time of 4 hours postdose. AUC represents drug exposure over the stated sampling interval, using measured concentrations across time rather than a single concentration reading. The endpoint is reported in nanograms*hour per milliliter, with a geometric mean and geometric coefficient of variation specified as the summary measures.
Pharmacokinetic endpoints are used to characterize how the body is exposed to a drug at different doses. In a dose-ranging study, that information can help describe whether exposure varies across tested dose levels. It is not itself a clinical outcome such as pain or a hemorrhagic event, and it does not establish that a dose improves health outcomes.
For Part A, the record specifies AUC results by administered doses from 0.03 to 0.6 mg/kg. For Part B, it specifies doses of 0.06, 0.08, and 0.12 mg/kg. Sampling times are 0.5, 1, 1.5, 2, and 4 hours postdose. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected, a detail relevant when interpreting observations across visits. The registry record does not report numerical AUC estimates or their variability.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a pharmacokinetic dose-ranging study, not a randomized efficacy comparison. Its primary endpoint is exposure to prasugrel active metabolite, measured by AUC through 4 hours postdose. Although the record specifies the doses, sampling times, and summary measures, it does not report numerical primary-endpoint results. Consequently, the posted information does not show the observed exposure at any dose, how exposure differed between dose levels, or how precisely those estimates were measured.
The study is recorded as nonrandomized, unmasked, and single group. Part A and Part B are dosing phases, not randomized treatment and control arms. Any differences across their dose levels or phases could not be interpreted as the result of a randomized comparison on the basis of the record. The design description also notes repeated dosing visits for four participants at the same dose, so observations from visits should not automatically be treated as independent participant-level evidence.
The record lists secondary outcomes concerning inactive-metabolite pharmacokinetics, participants with pain, and participants with hemorrhagic events requiring medical intervention. It does not provide numerical results for these outcomes in the registry record for this analysis. The safety information does give affected-participant counts for serious and other adverse events in named groups, but these counts are descriptive and do not establish that an event was caused by prasugrel. No deaths are reported in the registry record.
In general, a geometric mean summarizes measurements on a multiplicative scale and is often used for pharmacokinetic quantities that are positive and vary proportionally. A geometric coefficient of variation describes relative dispersion on that scale. These measures can characterize typical exposure and variability, but neither can be interpreted without the corresponding estimates and an understanding of how observations were handled. Those numerical estimates and analysis details are not reported in the registry record.
There is no sponsor analysis of the primary endpoint listed among the analyses in this record, and no numerical primary outcome estimate to compare with a recalculation. A conclusion about the magnitude, direction, or precision of the exposure pattern would therefore go beyond what the posted results establish. The dosing scheme and endpoint definition describe what was assessed; they do not substitute for the outcome estimates.
9. Statistical Methods Explained
The registry identifies the primary outcome as pharmacokinetic AUC for prasugrel active metabolite. It specifies a geometric mean and geometric coefficient of variation. It does not provide numerical endpoint estimates, confidence intervals, or an analysis description. The concepts below explain how such summaries are generally used; they are not claims about analyses performed in this study.
What does AUC measure?
In general, the area under a concentration-time curve summarizes exposure over a stated period. Concentration measurements are collected at scheduled times, then used to characterize the area across the interval. Here, the endpoint is AUC from time 0 to the last sampling time of 4 hours postdose, with samples scheduled at 0.5, 1, 1.5, 2, and 4 hours postdose. The record calls this AUC(0-tlast). It does not provide the underlying concentrations or explain the calculation method used to derive AUC.
AUC is distinct from a single postdose concentration. A single measurement describes concentration at a particular sampling time, whereas AUC represents exposure across the specified interval. AUC(0-tlast) is limited to the last sampling time named in the record; it is not a measure of exposure beyond that interval. The record does not report extrapolated exposure after the last sampling time.
Why report a geometric mean?
In general, pharmacokinetic measurements are positive quantities and may vary proportionally rather than by a fixed additive amount. A geometric mean is calculated on a logarithmic scale and then expressed on the original scale. It represents a typical value in a multiplicative framework. It should not be confused with an arithmetic average, and it does not provide the range of individual participant values.
The geometric coefficient of variation is a measure of relative spread around a geometric mean. In general, it conveys how variable observations are in proportion to their level. It is not the same as a standard deviation in the original measurement units. The registry specifies this dispersion measure but does not report its values, the number of observations contributing at each dose, or the method for handling repeated visits.
How should the dose descriptions be read?
Part A covered single doses from 0.03 to 0.60 mg/kg, titrated based on desired platelet inhibition, and Part B used once-daily doses expected to achieve mean platelet activation inhibition of 30% and 50%. The stated pharmacokinetic doses for Part B were 0.06, 0.08, and 0.12 mg/kg. These are dose descriptions, not estimates of the primary endpoint. The fact that a dose was expected to achieve a platelet inhibition target does not show that the target was observed, nor does it establish an exposure-response relationship.
The record states that four participants received the same dose at multiple visits where pharmacokinetic samples were collected. In general, repeated observations from the same participant can be correlated. Analyses that treat such observations as independent may understate uncertainty if within-participant dependence is not accounted for. The registry does not report how repeated observations were handled, so no particular method should be assumed.
What does the study design permit?
In general, a nonrandomized, single-group dose-ranging study can describe measurements observed under the evaluated dosing conditions. Without randomized allocation to a control, contrasts between dose levels do not have the same protection against differences in participant characteristics and study conditions that randomization can provide. Open-label status means masking was absent; the record does not describe whether this could have affected endpoint measurement or other procedures. These design features do not invalidate descriptive pharmacokinetic information, but they limit causal interpretation.
The registry lists enrollment of 33, but does not report a sample-size justification or statistical plan. Enrollment alone does not establish the precision of an endpoint estimate. Precision depends on the observed data and analysis, and no numerical AUC estimates or confidence intervals are reported. The record also does not report interim analyses, prespecified dose-comparison tests, or a model for dose-response.
What is the role of confidence intervals?
In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method. A narrower interval indicates greater precision under those assumptions; a wider interval indicates greater uncertainty. An interval does not remove possible bias from study design or missing data. Since the registry record does not report confidence intervals for the primary endpoint, its precision cannot be evaluated from the posted results.
Likewise, a p-value would address compatibility between data and a specified null hypothesis under a statistical model, not the size or clinical importance of an effect. No primary-endpoint p-value or hypothesis test is reported. The study's endpoint is exposure, and no clinical benefit claim follows from a pharmacokinetic summary alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies five outcome measures, including the primary pharmacokinetic outcome and secondary outcomes concerning inactive-metabolite pharmacokinetics, pain, and hemorrhagic events requiring medical intervention. The record does not report how many endpoints were considered in any formal testing strategy, whether a hierarchy was specified, or whether adjustments for multiple comparisons were planned. These multiplicity details are not reported in the registry record.
The registry lists no analysis entries for the outcomes in the information used for this analysis. It does not report a statistical analysis plan, hypothesis tests, confidence intervals, or endpoint estimates. It also does not state whether any analyses were interim or whether the endpoint definitions or analysis populations changed during the study. Those details are not reported in the registry record.
The primary endpoint population is described as participants who received at least 1 dose of prasugrel. The record does not give a corresponding analysis population for each dose, a participant flow, or the number of participants with evaluable pharmacokinetic samples at each dose and sampling time. It notes that four participants received the same dose at multiple visits, but does not explain how repeat observations were represented in the analysis.
Missing-data methods are not reported in the registry record. It is not stated how missing concentrations, incomplete sampling profiles, or participants without an evaluable AUC were handled. Without these details, it is not possible to determine whether the endpoint summaries, if available, would represent all participants who received a dose or a subset with usable measurements. The record also does not report reasons for missing measurements or sensitivity analyses addressing missingness.
These omissions matter because endpoint selection, repeated measurements, and incomplete sampling can affect both the estimate and its uncertainty. No analysis approach should be inferred from the outcome labels alone.
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 |
|---|---|---|---|
| Part A: Prasugrel Single Dose | 2 | 15 | 13.3% |
| Part B: Prasugrel Once-Daily Dose | 2 | 9 | 22.2% |
| Part A and Part B Participants: During Part A | 0 | 9 | 0.0% |
| Part A and Part B Participants: During Part B | 0 | 9 | 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 |
|---|---|
| Part A: Prasugrel Single Dose | 5 of 15 |
| Part B: Prasugrel Once-Daily Dose | 4 of 9 |
| Part A and Part B Participants: During Part A | 6 of 9 |
| Part A and Part B Participants: During Part B | 6 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Part A: Prasugrel Single Dose | Part B: Prasugrel Once-Daily Dose | Part A and Part B Participants: During Part A | Part A and Part B Participants: During Part B |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | 2 of 15 | 1 of 9 | 0 of 9 | 0 of 9 |
| Hypersplenism | Blood and lymphatic system disorders | 0 of 15 | 1 of 9 | 0 of 9 | 0 of 9 |
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 9 | 0 of 9 | 0 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part A: Prasugrel Single Dose | Part B: Prasugrel Once-Daily Dose | Part A and Part B Participants: During Part A | Part A and Part B Participants: During Part B |
|---|---|---|---|---|---|
| Sickle cell anaemia | Congenital, familial and genetic disorders | 1 of 15 | 0 of 9 | 2 of 9 | 3 of 9 |
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | 2 of 15 | 1 of 9 | 2 of 9 | 1 of 9 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 15 | 1 of 9 | 0 of 9 | 0 of 9 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 9 | 0 of 9 | 2 of 9 |
| Pyrexia | General disorders | 0 of 15 | 1 of 9 | 0 of 9 | 1 of 9 |
| Otitis media | Infections and infestations | 1 of 15 | 0 of 9 | 1 of 9 | 0 of 9 |
| Excoriation | Injury, poisoning and procedural complications | 0 of 15 | 1 of 9 | 0 of 9 | 1 of 9 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 0 of 9 | 2 of 9 | 0 of 9 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 1 of 9 | 0 of 9 | 1 of 9 |
| Middle ear effusion | Ear and labyrinth disorders | 0 of 15 | 0 of 9 | 0 of 9 | 1 of 9 |
Serious events with the highest arm-level rate: sickle cell anaemia with crisis (13.3%), hypersplenism (11.1%), acute chest syndrome (6.7%).
The registry reports serious and other adverse-event participant counts in four named groups. In Part A: Prasugrel Single Dose, 2 of 15 participants at risk were reported with serious adverse events, and 5 of 15 with other adverse events. In Part B: Prasugrel Once-Daily Dose, 2 of 9 were reported with serious adverse events, and 4 of 9 with other adverse events.
For Part A and Part B participants during Part A, the record lists 0 of 9 with serious adverse events and 6 of 9 with other adverse events. For Part A and Part B participants during Part B, it also lists 0 of 9 with serious adverse events and 6 of 9 with other adverse events. The group labels indicate that these are different study-part descriptions, and they should not be added together to create a participant total.
The serious adverse-event terms listed with percentages are sickle cell anaemia with crisis at 13.3%, hypersplenism at 11.1%, and acute chest syndrome at 6.7%. The registry record does not provide enough detail in the registry record to assign those terms to a particular dosing group or to infer causation. The listed counts describe what was recorded, not whether prasugrel caused an event. Deaths are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
This record describes a completed, open-label, nonrandomized, single-group phase 2 study designed to evaluate prasugrel dosing in pediatric participants with sickle cell disease. Its primary endpoint is active-metabolite exposure measured as AUC through 4 hours postdose. The record supplies the endpoint definition, scheduled sampling times, dose levels, and summary measures, but does not report numerical primary-endpoint results.
Accordingly, the posted information does not establish what exposure was observed at any dose, whether exposure increased or decreased across doses, or how much uncertainty surrounded any estimate. It also does not establish a clinical effect on pain, hemorrhagic events, or another health outcome. Those outcomes are named in the record, but their numerical results are not reported in the registry record for this analysis.
The adverse-event counts provide descriptive safety information for the groups as labeled. They do not establish that prasugrel caused the events or permit a randomized comparison. The group descriptions include participants across study parts, and the repeated group labels should not be treated as independent sets of participants or combined into a total.
In general, pharmacokinetic findings can help characterize drug exposure under specific dosing conditions. Such findings alone do not demonstrate clinical benefit or determine an appropriate dose for an individual. This study's registry record does not report the estimates needed to characterize exposure, and it does not provide a randomized control group for a causal treatment comparison.
The study should therefore be read as a dose-ranging investigation with a clearly named pharmacokinetic endpoint but without posted numerical primary results in this record. Any stronger claim about the magnitude, precision, or clinical implications of the findings would require information not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between a dose-ranging pharmacokinetic question and a clinical treatment comparison. Its primary endpoint measures active-metabolite exposure, while the registry also names outcomes related to pain and hemorrhagic events. Those endpoints address different questions. Exposure summaries can describe pharmacokinetics, but do not directly answer whether a clinical outcome changed.
The study's nonrandomized, single-group structure is important when interpreting contrasts across dosing phases or dose levels. Such contrasts can be useful descriptively, but they are not randomized comparisons. The record also notes repeated dose visits for four participants. Repeated observations may carry within-participant dependence, so a clear analysis description would be needed to assess how they contributed to estimates and uncertainty.
Another statistical issue is the relationship between an endpoint's definition and the information needed to interpret it. The record specifies AUC(0-tlast), sampling times, a geometric mean, and a geometric coefficient of variation. Those details clarify what was intended to be summarized. However, without the estimates and dispersion values, readers cannot assess the exposure pattern or its precision.
The record lists multiple outcome measures but does not report a multiplicity strategy, missing-data methods, or an analysis plan. Those omissions limit assessment of how results were selected, how incomplete profiles were handled, and whether repeated measurements were accounted for. The listed safety counts remain useful descriptive information, but cannot substitute for the missing endpoint analyses or a randomized comparison.
Overall, the record illustrates why design, endpoint type, and reporting completeness must be considered together. The dosing and measurement framework is described, while the numerical primary results and key analysis details are not reported in the registry 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 principal limitation for interpreting the primary endpoint is that numerical AUC results are not reported in the registry record. Although the dose levels, sampling times, endpoint unit, and summary measures are specified, there are no estimates or variability values to assess. The record also does not report confidence intervals or other measures of precision.
The study was nonrandomized, unmasked, and single group. Dose-level and study-part descriptions therefore do not provide randomized control comparisons. The registry does not report a control group or details that would allow assessment of potential differences in participant characteristics across dosing conditions.
The endpoint description notes that four participants received the same dose at multiple visits where pharmacokinetic samples were collected. The analysis method for these repeated observations is not reported. The record also does not provide dose-specific numbers with evaluable samples, participant flow, missing-data methods, or reasons for missing measurements. The handling of incomplete concentration profiles is therefore unclear.
The record names secondary outcomes but does not report their numerical results in the information used for this analysis. It also does not report multiplicity handling, a statistical analysis plan, a sample-size justification, or interim-analysis details. The Part B description specifies a 10-18 day period for the dose expected to achieve mean platelet activation inhibition of 30%, but the duration for the subsequent dose expected to achieve 50% is not reported in the registry record.
Finally, the serious adverse-event counts are descriptive and do not establish causation. The registry's group labels include study-part-specific descriptions, so counts should not be combined across overlapping labels. These reporting and design limitations constrain conclusions about exposure, uncertainty, and clinical outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease — NCT01476696.
- Registry record last updated 2014-02-13; status last verified 2014-01.
- Results first posted 2013-12-11.
- 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 record describes NCT01476696, a completed phase 2, open-label, nonrandomized, single-group study of prasugrel in pediatric participants with sickle cell disease. Enrollment is recorded as 33. The study began in 2011-11, with primary completion in 2012-11.
Part A evaluated single oral doses from 0.03 to 0.60 mg/kg. Part B evaluated once-daily dosing, including on-site doses of 0.06, 0.08, and 0.12 mg/kg for the primary pharmacokinetic endpoint. The primary endpoint was prasugrel active-metabolite AUC from time 0 to 4 hours postdose, summarized by geometric mean and geometric coefficient of variation.
The registry lists secondary outcomes related to inactive-metabolite pharmacokinetics, pain, and hemorrhagic events requiring medical intervention. It also reports serious and other adverse-event counts by study group. Numerical primary-endpoint results, analysis details, and missing-data methods are not reported in the registry record.