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 LY3006072 in Healthy Participants (NCT01640249), a randomized phase 1 study. The primary outcome is Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01640249 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy volunteers, with 18 participants recorded. The primary endpoint population is described as all randomized participants who received at least one dose of study drug. The record says LY3006072 was being given to humans for the first time in this study.
Intervention
Participants received LY3006072 capsules in escalating dose groups: 1 mg, 3 mg, 10 mg, 20 mg and 40 mg. The study description says administration was considered in the morning or evening, with or without a meal. The detailed timing and food conditions for each dose are not reported in the registry record.
Comparator
Placebo was the comparator. The record describes placebo capsules taken orally with approximately 200 to 300 milliliter of room temperature water in the morning. The study is classified as randomized, double-masked and crossover, but the treatment sequences and period details are not reported in the registry record.
Primary question
The primary outcome asks how many participants had one or more drug-related adverse events or any serious adverse events, from baseline up to 21 days. The registry also lists pharmacokinetic outcomes for maximum concentration and area under the concentration curve. The posted information does not include inferential comparisons or pharmacokinetic results.
In statistical terms, the central question is descriptive: what safety events were recorded in the listed placebo and dose groups? Because the design is crossover, participant-level treatment exposure may span more than one treatment condition. The posted counts should therefore be read as group-specific event summaries, not as proof that the groups are independent or as an adjusted treatment-effect estimate. The record does not report an analysis that accounts for within-participant comparisons.
3. Trial Design
This was a phase 1, randomized, double-masked, crossover study of LY3006072 in healthy participants. The recorded enrollment was 18. The study began on 2012-07-24, and primary completion was recorded on 2012-11-26. Its current status is terminated. The reason for termination is not reported in the registry record.
The study included placebo and LY3006072. The dose groups listed for LY3006072 were 1 mg, 3 mg, 10 mg, 20 mg and 40 mg, described as escalating doses. Placebo was given orally in the morning with approximately 200 to 300 milliliter of room temperature water. The overall study description says the drug could be given in the morning or evening, with or without a meal. Exact dose-specific schedules, treatment periods, washout intervals and randomization sequences are not reported in the registry record.
Randomization and double masking describe how treatment assignment and awareness of assignment were handled in broad terms. The crossover classification means the design involved treatment conditions within a crossover framework, but the registry entries do not establish how participants moved between conditions or how period and sequence effects were evaluated. Those design details and the statistical plan are not reported in the registry record.
The stated purpose was to evaluate safety and tolerability, as well as pharmacokinetics and pharmacodynamics. The record lists maximum concentration and area under the concentration curve as secondary pharmacokinetic outcomes. It does not report their results in the information summarized for the posted safety endpoint. The study is described as research and not intended to treat a medical condition.
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: This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.
Only the first 6 of 7 groups are shown.
Period 1
| Stage | Cohort 1 (Sequence 1) | Cohort 1 (Sequence 2) | Cohort 1 Sequence 3 | Cohort 1 Sequence 4 | Cohort 2 (Sequence 1) | Cohort 2 (Sequence 2) |
|---|---|---|---|---|---|---|
| STARTED | 3 | 2 | 2 | 2 | 2 | 5 |
| Received at Least 1 Dose of Study Drug | 3 | 2 | 2 | 2 | 2 | 5 |
| COMPLETED | 2 | 2 | 2 | 2 | 2 | 4 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | Cohort 1 (Sequence 1) | Cohort 1 (Sequence 2) | Cohort 1 Sequence 3 | Cohort 1 Sequence 4 | Cohort 2 (Sequence 1) | Cohort 2 (Sequence 2) |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 |
Period 2
| Stage | Cohort 1 (Sequence 1) | Cohort 1 (Sequence 2) | Cohort 1 Sequence 3 | Cohort 1 Sequence 4 | Cohort 2 (Sequence 1) | Cohort 2 (Sequence 2) |
|---|---|---|---|---|---|---|
| STARTED | 2 | 2 | 2 | 2 | 2 | 4 |
| COMPLETED | 2 | 2 | 2 | 2 | 2 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period 3
| Stage | Cohort 1 (Sequence 1) | Cohort 1 (Sequence 2) | Cohort 1 Sequence 3 | Cohort 1 Sequence 4 | Cohort 2 (Sequence 1) | Cohort 2 (Sequence 2) |
|---|---|---|---|---|---|---|
| STARTED | 2 | 2 | 2 | 2 | 0 | 0 |
| COMPLETED | 2 | 2 | 2 | 1 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least one dose of study drug.
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 randomized participants who received at least one dose of study drug.
Only the first 6 of 8 groups are shown.
| Characteristic | Unit | Cohort 1 (Sequence 1) | Cohort 1 (Sequence 2) | Cohort 1 (Sequence 3) | Cohort 1 (Sequence 4) | Cohort 2 (Sequence 1) | Cohort 2 (Sequence 2) |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 2 | 2 | 2 | 2 | 5 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 0 | 1 | 2 | 2 | 3 |
| Age, Categorical: >=65 years | Participants | 1 | 2 | 1 | 0 | 0 | 2 |
| Sex: Female, Male: Female | Participants | 1 | 2 | 2 | 2 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 2 | 0 | 0 | 0 | 1 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 2 | 2 | 2 | 2 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 2 | 2 | 2 | 2 | 2 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 3 | 2 | 2 | 2 | 2 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs, measured over Baseline, up to 21 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with one or more drug-related adverse events or any serious adverse events. Its timeframe is baseline up to 21 days. The population is all randomized participants who received at least one dose of study drug.
An event count is a direct way to describe how many participants experienced a safety event under the endpoint definition. The definition combines events considered possibly related to study drug, in the investigator’s opinion, with serious adverse events regardless of whether they were considered related. The record says summaries of serious and other non-serious adverse events, regardless of possible drug relatedness, are located in the Reported Adverse Event module. The counts discussed in the posted summary distinguish serious events from other events considered drug-related.
For an early study in healthy participants, safety and tolerability are central descriptive concerns, alongside the stated pharmacokinetic and pharmacodynamic aims. The event count itself does not measure event severity beyond the distinction between serious and other events, nor does it describe timing, duration or recurrence. Such details are not reported in the registry record. The registry also does not post a single analyzed primary-outcome comparison, so the counts should not be treated as an estimated comparative effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety data list zero serious adverse events in each group. For other drug-related adverse events, the counts are 0 among 9 participants in the placebo group, 3 among 6 in the 1 mg LY3006072 group, 1 among 6 in the 3 mg group, 1 among 6 in the 10 mg group, 2 among 6 in the 20 mg group and 6 among 6 in the 40 mg group. These are counts, not percentages or adjusted estimates.
The pattern of non-serious drug-related event counts varies across the listed dose groups. It is descriptive evidence from this study record, not a formal test of a dose trend. The registry reports no analyses for the primary outcome and no inferential comparison, confidence interval or p-value. It also does not report a model accounting for the crossover design. The counts alone therefore do not establish whether observed differences reflect treatment, chance, period effects or other features of the study.
The group denominators are small: the placebo summary lists 9 participants at risk, and each LY3006072 dose summary lists 6. The total enrollment is 18, but those group counts should not be added together to infer a number of unique participants because the design is classified as crossover. Whether the same participants contributed to multiple dose summaries, and how records were handled across treatment periods, is not detailed in the registry record. A participant may therefore appear in more than one exposure summary, but the exact pattern cannot be established from the posted information.
The endpoint definition includes any serious adverse event, regardless of relatedness, alongside drug-related events. The serious-event counts are zero in each listed group, while the other-event counts refer to events considered possibly related to study drug by the investigator. The record does not provide event-level detail in these counts, and the most common serious-event terms list is empty. Death counts are not reported in the registry record.
The registry labels the study terminated but does not report the reason. It also does not report a primary-outcome analysis or results for the listed pharmacokinetic outcomes in this information. The appropriate reading is thus limited: the posted counts describe reported event experience in the listed groups over the stated period, while uncertainty about the treatment comparison remains unquantified.
9. Statistical Methods Explained
What does an event count describe?
General: For a binary safety outcome, each participant is classified according to whether the defined event occurred during the observation period. A count states how many participants met that definition. It is distinct from an event total, because one participant can experience more than one event. The primary endpoint is phrased as participants with one or more qualifying events, so the intended unit is participants rather than episodes.
The posted summaries separate serious adverse events from other events considered drug-related. The primary endpoint combines drug-related events and serious events, but no single primary-outcome result is posted. The registry reports no analyses for the outcome and marks the primary outcome as having several categories or time points that were not reduced to one comparison. Consequently, the separate descriptive counts cannot be mistaken for a sponsor-reported estimate of the combined endpoint.
Why do denominators matter?
General: A count is most interpretable when its denominator and population are clear. The group summaries report participants at risk, while the primary endpoint population is all randomized participants who received at least one dose. Those definitions identify the intended scope of the safety summaries, but the registry does not explain in detail how missing observations or exposure across crossover periods were handled.
In a crossover design, a participant can be exposed to more than one treatment condition. Group-specific denominators may therefore describe treatment exposures rather than separate, independent sets of people. Treating each dose group as independent without knowing the sequence and analysis method can misstate the amount of independent information. The registry classifies the study as crossover but does not report sequence-level details or an analysis that accounts for repeated observations within a participant.
What would an inferential comparison add?
General: A comparative estimate would quantify the difference between treatment conditions under a specified analysis. A confidence interval would express the range of effect estimates compatible with the data and the model’s assumptions; it would also show the precision of the estimate. A hypothesis test could assess compatibility with a specified null hypothesis. None of these inferential results is reported for the primary endpoint in the registry record. No p-value or confidence interval should be inferred from the counts alone.
The small group counts mean the descriptive results are limited in how precisely they can characterize event frequency. In general, rare outcomes are particularly difficult to characterize with small samples: observing no event does not establish that the underlying event probability is zero. That general point does not supply an estimate for this study, and the registry reports no interval around the serious-event counts.
What does the crossover classification change?
General: Crossover designs can use within-participant comparisons, which may account for stable differences between participants. Such analyses require information about treatment sequence, period, carryover and the repeated measurements contributed by each participant. A valid analysis also needs a prespecified method for handling these design features. The registry does not report those details or a statistical analysis plan. It is therefore not possible to determine whether the posted summaries are period-specific, participant-level, or adjusted for the crossover structure.
The classification alone does not establish that every participant received every dose or placebo, nor does it reveal the order or timing of exposures. Those details are not reported in the registry record. The dose-group counts should be read as the recorded group summaries, without reconstructing a participant flow or treatment sequence.
How should planning calculations be understood?
General: Sample-size calculations describe design requirements under stated assumptions; they do not describe the precision actually achieved unless interpreted alongside the observed data and analysis. A planning illustration based on an observed effect is not observed power. The stated assumptions for planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the planning convention is participants per arm for the selected power; time-to-event planning counts total events.
These assumptions do not document the trial’s original design rationale. The registry does not report a sample-size justification or show that the study was planned around those assumptions. No sample-size illustration should be interpreted as an observed statistical result or as evidence that the study had a particular power to detect a safety difference.
Why might over-dispersion matter?
General: Over-dispersion occurs when observed variability exceeds what a statistical model assumes. For event counts, repeated events or clustering within participants can create more variability than a simple model allows. Accounting for this can change standard errors and the width of confidence intervals. The posted primary outcome is a participant count, and no fitted model or dispersion assessment is reported. It would therefore be inappropriate to assert that over-dispersion was assessed or corrected in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary safety outcome and two secondary pharmacokinetic outcomes: maximum concentration and area under the concentration curve for LY3006072. The posted results summarized for safety do not include pharmacokinetic estimates. The number of outcome measures is recorded as 3, while the number of analyses is recorded as 0.
Multiplicity arises when several outcomes, treatment comparisons, time points or subgroup analyses are considered. Without a stated analysis plan, it is not possible to tell whether or how the study controlled the risk of false-positive findings across multiple tests. The statistical plan, any hierarchy among outcomes, and any multiplicity adjustment are not reported in the registry record.
The primary safety endpoint was not reduced to one comparison because it has several categories or time points, according to the registry note. This means the posted information does not support a single inferential conclusion for the primary outcome. The event counts remain descriptive and should not be read as results of a formal test.
The primary population is described as randomized participants who received at least one dose. The registry does not report how missing safety observations were handled, whether all randomized participants were included in each analysis, or how crossover periods were incorporated. It also does not report a missing-data method, analysis population beyond the primary endpoint description, or sensitivity analyses. These omissions limit assessment of how fully the posted event summaries represent the randomized study population.
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 |
|---|---|---|---|
| Placebo | 0 | 9 | 0.0% |
| 1 mg LY3006072 | 0 | 6 | 0.0% |
| 3 mg LY3006072 | 0 | 6 | 0.0% |
| 10 mg LY3006072 | 0 | 6 | 0.0% |
| 20 mg LY3006072 | 0 | 6 | 0.0% |
| 40 mg LY3006072 | 0 | 6 | 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 |
|---|---|
| Placebo | 0 of 9 |
| 1 mg LY3006072 | 3 of 6 |
| 3 mg LY3006072 | 1 of 6 |
| 10 mg LY3006072 | 1 of 6 |
| 20 mg LY3006072 | 2 of 6 |
| 40 mg LY3006072 | 6 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | 1 mg LY3006072 | 3 mg LY3006072 | 10 mg LY3006072 | 20 mg LY3006072 | 40 mg LY3006072 |
|---|---|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | 0 of 9 | 3 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 6 of 6 |
| Dizziness | Nervous system disorders | 0 of 9 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 1 of 6 |
| Dry mouth | Gastrointestinal disorders | 0 of 9 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 |
| Nausea | Gastrointestinal disorders | 0 of 9 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 9 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 0 of 9 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 |
| Memory impairment | Nervous system disorders | 0 of 9 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 |
| Insomnia | Psychiatric disorders | 0 of 9 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 6 |
The registry lists zero serious adverse events among participants at risk in each group: 9 for placebo and 6 for each LY3006072 dose group. The other drug-related adverse event counts are 0 for placebo, 3 for 1 mg, 1 for 3 mg, 1 for 10 mg, 2 for 20 mg and 6 for 40 mg. The non-serious event counts are events considered possibly related to study drug in the investigator’s opinion.
A zero serious-event count means none were recorded in the posted group summary; it does not demonstrate that the underlying risk is zero. The registry does not report confidence intervals or an inferential analysis for these counts. Because the study is classified as crossover, group denominators may not represent distinct, independent participants. Treatment sequence and repeated-exposure handling are not reported in the registry record.
The endpoint timeframe is baseline up to 21 days. The record does not report deaths in the group summaries. The event counts should therefore be read as descriptive reports for the listed groups and timeframe, not as a definitive comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The posted results describe how many participants in each listed treatment group had drug-related events other than serious events, and how many had serious events. They show zero serious adverse events in the listed groups and varying counts of other drug-related events across the LY3006072 dose summaries. These observations characterize the safety reporting captured in the registry record for the stated period.
They do not establish a causal treatment effect or a statistically reliable difference between placebo and any LY3006072 dose. No primary-outcome analysis, confidence interval or p-value is reported. The registry’s crossover classification also means the dose-group summaries cannot automatically be treated as independent groups, and the participant-level sequences and analysis method are not reported.
The counts do not establish that an event could not occur outside the observation timeframe, that all possible adverse events were captured in these summaries, or that the event pattern would be the same in a different population. The study involved healthy participants, and the record states it was not intended to treat a medical condition. Its stated aims also included pharmacokinetics and pharmacodynamics, but results for the listed pharmacokinetic outcomes are not reported in the posted information.
The record is marked terminated, but the reason is not reported in the registry record. That status alone does not explain why the study ended or how it affected the data. The most defensible interpretation is descriptive: the registry posts small group counts for specified event categories, while the precision and comparative meaning of those counts remain unquantified.
13. Why This Trial Matters Statistically
This study illustrates why event counts and treatment-effect estimates are not interchangeable. Safety counts can make the observed data easy to read, but counts without comparative modeling do not quantify uncertainty or establish whether group differences are compatible with chance. The absence of a reported primary-outcome analysis is therefore important when interpreting the apparent variation across dose groups.
The crossover design adds a further statistical issue. Participants may contribute information under more than one treatment condition, so analyses may need to account for within-person dependence and treatment period. The design label is informative, but without sequence details and an analysis description it is not possible to assess how those features were handled. Simply comparing listed counts as though they came from unrelated groups could overlook this structure.
The record also shows the distinction between a safety endpoint and the broader study aims. It identifies safety and tolerability as central objectives and lists pharmacokinetic outcomes, but the posted information does not report results for those concentration measures. A registry entry can therefore provide useful design and descriptive safety information without documenting every analysis needed to answer the study’s broader questions.
Finally, the record’s terminated status and absent analysis details highlight the importance of transparency about study conduct, analysis populations, missing data and the reasons for study completion. Those details help readers judge whether descriptive results are complete and how narrowly they should be interpreted.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry identifies the study as terminated but does not report why it was terminated. The available record does not explain whether termination affected enrollment, follow-up, the planned outcomes or the completeness of data. It would be inappropriate to infer a reason from the status alone.
Although the study is classified as randomized, double-masked and crossover, the registry entries do not describe allocation sequences, treatment periods, washout intervals or the handling of repeated observations. Those omissions are particularly relevant to interpretation of dose-group counts in a crossover design. The record does not report whether the posted denominators represent unique participants or exposure periods.
The primary endpoint covers baseline up to 21 days, but details about event ascertainment at particular visits, missing observations and follow-up completeness are not reported in the registry record. The endpoint definition also groups drug-related events and serious events, while the posted summary separates serious from other drug-related event counts. No combined primary-endpoint estimate is posted.
The group counts are limited in size, and no precision estimates or formal comparisons are reported. The registry does not provide an analysis plan, a sample-size justification, multiplicity procedures or sensitivity analyses. The two listed pharmacokinetic outcomes have no results in the posted information summarized for this endpoint. These limitations leave the record useful for describing the listed event counts, but insufficient for reconstructing a complete inferential analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of LY3006072 in Healthy Participants — NCT01640249.
- Registry record last updated 2019-08-08; status last verified 2019-06.
- Results first posted 2019-08-08.
- 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
NCT01640249 is a phase 1 randomized, double-masked, crossover study of LY3006072 and placebo in healthy participants. Enrollment was 18. The study began on 2012-07-24, primary completion was recorded on 2012-11-26, and the status is terminated.
The primary outcome concerns participants with one or more drug-related adverse events or any serious adverse events from baseline up to 21 days. The posted safety summaries report zero serious adverse events in each listed group and non-serious drug-related event counts ranging from 0 in the placebo group to 6 in the 40 mg group. No primary-outcome analysis or inferential comparison is reported in the registry record. The reason for termination, crossover sequence details, missing-data handling and results for the listed pharmacokinetic outcomes are not reported in the registry record.