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 Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults (NCT04472650), a randomized phase 1 study. The primary outcome is Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04472650 |
| Phase | Phase 1 |
| Condition | Tumor |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 26 |
| Arms in the primary outcome | 2 |
| Lead sponsor | BeiGene |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adults who received at least one dose of sitravatinib and had at least one sitravatinib pharmacokinetic parameter were eligible for the primary pharmacokinetic analysis set. The registry lists 26 participants enrolled. The listed condition is Tumor, while the study title and summary describe healthy adults; the registry record does not explain this difference.
Intervention
One formulation was a sitravatinib free base capsule, given as a single 120 mg dose on Day 1 of a study period. Participants in the other sequence received the malate salt capsule first, at a single 100 mg dose.
Comparator
The comparison was between the free base capsule and the malate salt capsule. Participants were randomized to one of two sequences: free base followed by malate salt, or malate salt followed by free base. A minimum washout period of 14 days separated the dose administrations.
Primary question
The primary objective was to investigate the relative bioavailability and pharmacokinetics of the formulations. The primary endpoint was sitravatinib AUC from time zero to infinity. The registry reports a ratio of geometric least-squares means of 87.63, with a 90% confidence interval from 78.273 to 98.111. The analysis record does not explicitly identify which formulation is the numerator.
3. Trial Design
This was a Phase 1, open-label, single-dose, randomized crossover study. The registry lists 26 participants enrolled and the study status as completed. The recorded study dates are 2020-07-23 for the start and 2020-11-09 for primary completion. BeiGene is listed as the sponsor.
In a crossover design, each participant receives more than one study treatment in sequence. In general, this allows a participant’s response under one treatment to be compared with their response under another, while accounting for the fact that measurements can differ between people. A crossover comparison also depends on adequate separation between treatments and appropriate analysis of sequence and period. The registry describes a minimum washout period of 14 days between dose administrations. It does not report how the washout duration was selected or whether carryover was assessed.
Participants were randomized to one of two dosing sequences. In the first, the free base capsule was given in Period 1 and the malate salt capsule in Period 2. In the second, the order was reversed. Each treatment was administered once on Day 1 of its period: 120 mg for the free base capsule and 100 mg for the malate salt capsule. The study was open-label, meaning masking was not used.
The primary pharmacokinetic endpoint was evaluated using the pharmacokinetic analysis set. The registry defines that set as participants who received at least one dose and had at least one sitravatinib pharmacokinetic parameter. The endpoint-specific participant counts were 25 for the malate salt capsule and 26 for the free base capsule. The registry does not report the number assigned to each dosing sequence or explain why the endpoint counts differ.
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.
Period 1 (Up to 15 Days)
| Stage | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule |
|---|---|---|
| STARTED | 13 | 13 |
| COMPLETED | 13 | 13 |
| NOT COMPLETED | 0 | 0 |
Washout Period (Minimum 14 Days)
| Stage | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule |
|---|---|---|
| STARTED | 13 | 13 |
| COMPLETED | 12 | 13 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule |
|---|---|---|
| Adverse Event | 1 | 0 |
Period 2 (Up to 15 Days)
| Stage | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule |
|---|---|---|
| STARTED | 12 | 13 |
| COMPLETED | 12 | 13 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib
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: Safety Analysis Set included participants who received at least 1 dose of sitravatinib
| Characteristic | Unit | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 13 | 26 | |
| Age, Continuous | Years | 27.1 (SD 4.23) | 28.2 (SD 10.19) | 27.7 (SD 7.67) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 13 | 13 | 26 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 | 13 | 26 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 8 | 9 | 17 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 3 | 3 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib, measured over Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | h*ng/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was sitravatinib area under the concentration-time curve from time zero to infinity, abbreviated AUC0-∞. It was measured in h*ng/mL. The registry lists predose and postdose sampling at 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours in each study period.
In general, AUC represents the area under a drug concentration-versus-time profile. It is used in pharmacokinetic comparisons because it summarizes exposure over time rather than relying on a concentration at a single measurement time. Extending the measure to infinity includes an estimated portion of the concentration profile beyond the last observed sampling time. The registry record does not describe how that terminal portion was estimated.
The endpoint is reported as a geometric mean, with geometric coefficient of variation as the measure of dispersion. In general, geometric summaries are useful when pharmacokinetic measurements are positive and skewed, since analysis on a logarithmic scale can make relative differences easier to describe. A geometric coefficient of variation describes variability on a proportional scale; it is not the same quantity as a standard deviation. The registry does not provide further details of the calculation or model.
AUC is one measure of relative exposure, not a direct measure of clinical benefit. This study’s stated primary objective was to compare relative bioavailability and pharmacokinetics of the two formulations in healthy adults.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports geometric mean AUC values of 2525.0 h*ng/mL for the malate salt capsule and 2893.0 h*ng/mL for the free base capsule. The corresponding participant counts are 25 and 26. The reported geometric coefficients of variation are 28.8 and 34.5, respectively. These are descriptive summaries of the endpoint distributions in the pharmacokinetic analysis set.
For the comparison, the registry reports a ratio of geometric least-squares means of 87.63 and a 90% confidence interval from 78.273 to 98.111. The analysis lists the malate salt and free base groups in that order, but does not explicitly state which is the numerator. The result should therefore be read as the registry’s reported formulation contrast, without assigning a direction to the ratio beyond what the record states.
In general, a confidence interval describes the range of estimates compatible with the data and the statistical method under the model’s assumptions. Its width conveys precision: a narrower interval indicates a more precise estimate than a wider one, all else being equal. The reported interval gives a range of plausible values for the ratio, but it does not capture every source of uncertainty, such as limitations in the study design or unreported analysis choices.
The registry does not report a p-value for this comparison. The confidence interval is reported at the 90% level. No conclusion about clinical importance follows from the ratio alone; the record does not specify a threshold for an important difference or describe a clinical decision rule. The study was conducted in healthy adults and focused on pharmacokinetic measures, so the posted result should be interpreted within that context.
The two formulations were administered at different stated dose amounts: 120 mg for free base and 100 mg for malate salt. The posted endpoint comparison is a formulation comparison as reported by the registry, but the record does not describe any dose normalization or adjustment. That omission limits what can be inferred about whether the contrast isolates formulation alone from other features of the dosing regimens.
The results are based on the participants included in the pharmacokinetic analysis set, rather than necessarily every person enrolled. The record lists 26 enrolled, with 25 and 26 participants contributing to the endpoint summaries for the two formulations. It does not describe the reasons for any difference between enrollment and analysis counts, or how missing pharmacokinetic measurements were handled.
9. Statistical Methods Explained
The primary analysis compares a pharmacokinetic endpoint between two capsule formulations in a randomized crossover study. The registry describes the endpoint as AUC from time zero to infinity and reports geometric means, geometric coefficients of variation, and a ratio of geometric least-squares means. It does not report the statistical method used to estimate that ratio, so details of the fitted model and its assumptions cannot be established from the record.
What does the geometric summary represent?
In general, a geometric mean is obtained by taking the mean on a logarithmic scale and converting the result back to the original scale. This approach is often used for positive concentration and exposure measurements when values are right-skewed. It gives a summary that is naturally interpreted in relative, rather than additive, terms. The registry’s reported geometric means are 2525.0 h*ng/mL for malate salt and 2893.0 h*ng/mL for free base.
A geometric coefficient of variation describes relative dispersion around a geometric summary. The registry reports values of 28.8 for malate salt and 34.5 for free base. The record identifies the dispersion measure but does not explain its calculation or specify any additional distributional summaries. These measures describe variability among the analyzed participants; they do not, by themselves, quantify uncertainty in the contrast between formulations.
How should the ratio and interval be read?
A ratio of geometric least-squares means compares model-based geometric means. In general, a value of 100 on this type of scale corresponds to equal values in the numerator and denominator; values on either side indicate a relative difference whose direction depends on how the ratio was defined. The registry reports a value of 87.63, with a 90% confidence interval from 78.273 to 98.111. The record gives the groups in the comparison but does not explicitly identify the numerator. It also does not report the model used to obtain the least-squares means.
In general, a confidence interval expresses uncertainty in an estimated quantity under a specified method and its assumptions. Its endpoints are not a range containing a fixed proportion of individual participant measurements. Nor does the interval by itself establish clinical importance. The registry does not state a prespecified equivalence range, a decision threshold, or a p-value for the formulation contrast.
Why does the crossover structure matter?
In general, crossover studies make within-participant comparisons possible because a participant receives each study treatment in a sequence. This can reduce the influence of stable differences between participants. It also creates analysis considerations: treatment, period, sequence, and possible carryover can affect interpretation. The registry records randomized allocation to two sequences and a minimum washout period of 14 days. It does not report whether the primary model included period or sequence terms, how carryover was considered, or how the washout period was justified.
The crossover design should not be treated as if participants were assigned permanently to separate treatment groups. The posted endpoint counts refer to participants represented for each formulation, and the registry does not provide a participant-level accounting of completed periods or paired observations. Without that detail, the extent to which the reported comparison uses paired data cannot be assessed from the record.
What role do the sampling times play?
The registry lists predose sampling and measurements at 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours after dosing in each period. In general, concentration-time measurements support estimation of the exposure profile. The observed sampling schedule is relevant because AUC from time zero to infinity includes both the observed portion of the profile and an estimate of exposure beyond the final measurement. The record does not describe the estimation procedure, assay details, handling of values below measurement limits, or criteria for evaluating the terminal part of the profile.
What do the planning assumptions mean?
Planning calculations based on an observed effect are hypothetical illustrations, not observed power and not a record of the trial’s original design justification. In general, a sample-size illustration uses assumptions about the effect to detect, variability, significance level, allocation, and statistical approximation. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such assumptions describe a calculation framework; they do not establish that the trial was designed or analyzed using that framework.
The stated equal-allocation assumption is framed in terms of two arms, whereas the recorded study is a crossover with two dosing sequences and each participant receiving both formulations. Those are different design descriptions, so any planning illustration should not be read as a reconstruction of the actual crossover design. The registry does not report the original sample-size justification, power target, or planning method.
Overall, the posted analysis gives a compact description of exposure and a relative contrast, but important analytic details are not reported in the registry record. These include the model specification, treatment of period and sequence, handling of incomplete profiles, and procedures for missing observations. Those omissions prevent a full independent assessment of the statistical assumptions underlying the reported ratio and interval.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Ratio of Geometric Least Squares Means 87.63 | 78.273 to 98.111 | not reported |
The registry’s posted comparison is a ratio of geometric least-squares means of 87.63, with a 90% confidence interval from 78.273 to 98.111. The record does not report the method used for the sponsor’s analysis, does not identify the numerator explicitly, and does not provide a p-value.
The posted endpoint summaries give geometric means of 2525.0 h*ng/mL for the malate salt capsule and 2893.0 h*ng/mL for the free base capsule. Those descriptive values are not the same as the ratio of geometric least-squares means: the latter is a model-based contrast, and the registry does not describe its model. Any simple unadjusted recalculation from summary statistics would not reproduce model adjustments that are not documented in the record.
No discrepancy is flagged between the posted result and the recalculation record. The sponsor’s own analysis takes precedence when a discrepancy exists; none is flagged in this case. Because the registry does not report the analysis method, the reported sponsor contrast remains the appropriate result to quote, while its assumptions and exact direction cannot be fully reconstructed from the posted record.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures and three analyses, and identifies the number of participants with adverse events as a secondary outcome. It does not report a multiplicity procedure, such as an adjustment across outcomes or analyses, or explain whether any endpoints were considered confirmatory or exploratory. Without that information, the relationship between the primary comparison and other analyses cannot be fully assessed.
The primary pharmacokinetic analysis set is defined as participants who received at least one dose of sitravatinib and had at least one sitravatinib pharmacokinetic parameter. The endpoint summaries include 25 participants for the malate salt capsule and 26 for the free base capsule. The registry does not provide a participant flow accounting, reasons for exclusion, or details of how incomplete profiles affected inclusion in the AUC analysis.
Missing-data handling is not reported in the registry record. In general, this matters because missing concentration measurements can affect exposure estimation, particularly when measurements near the end of a profile contribute to estimating AUC from time zero to infinity. The record does not say whether missing measurements were imputed, whether an endpoint could be calculated with partial profiles, or what rules were applied to unusable pharmacokinetic data.
The registry also does not report the statistical analysis plan, interim analyses, or the protocol’s sample-size justification. It does not describe how period or sequence effects were treated in the crossover analysis. These omissions limit assessment of the analysis population, missingness, multiplicity, and model assumptions; they do not establish that a particular procedure was or was not used.
12. 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 |
|---|---|---|---|
| Sitravatinib Malate Salt Capsule | 0 | 25 | 0.0% |
| Sitravatinib Free Base Capsule | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sitravatinib Malate Salt Capsule | 0 of 25 |
| Sitravatinib Free Base Capsule | 0 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sitravatinib Malate Salt Capsule | 10 of 25 |
| Sitravatinib Free Base Capsule | 8 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sitravatinib Malate Salt Capsule | Sitravatinib Free Base Capsule |
|---|---|---|---|
| Vessel puncture site bruise | General disorders | 3 of 25 | 0 of 26 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 1 of 25 | 2 of 26 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 25 | 1 of 26 |
| Catheter site pain | General disorders | 1 of 25 | 1 of 26 |
| Vessel puncture site pain | General disorders | 2 of 25 | 0 of 26 |
| Alanine aminotransferase increased | Investigations | 2 of 25 | 0 of 26 |
| Headache | Nervous system disorders | 1 of 25 | 1 of 26 |
| Anaemia | Blood and lymphatic system disorders | 0 of 25 | 1 of 26 |
| Abdominal discomfort | Gastrointestinal disorders | 0 of 25 | 1 of 26 |
| Diarrhoea | Gastrointestinal disorders | 1 of 25 | 0 of 26 |
For the malate salt capsule, 25 participants were at risk for serious adverse events, and zero were reported as affected. For the free base capsule, 26 participants were at risk, and zero were reported as affected. Deaths were reported as zero in both groups. The registry lists no serious adverse-event terms.
The separate counts for participants with other adverse events were 10 for malate salt and 8 for free base. These counts are not the serious adverse-event counts and should not be interpreted as such. The registry’s secondary outcome is the number of participants with adverse events; the record does not provide event-level detail or describe the severity and timing of the other adverse events in this summary.
In general, observing zero serious events in a group does not establish that the risk is absent. These figures describe what was recorded among the participants at risk in this study, and the study was a Phase 1 crossover study in healthy adults. The safety counts are descriptive; the record does not report a statistical comparison of adverse-event rates between formulations.
13. What the Result Does, and Does Not, Mean
The posted findings describe a pharmacokinetic comparison of two sitravatinib capsule formulations in healthy adults. The primary measure was AUC from time zero to infinity, a summary of drug exposure over time. The registry reports geometric mean AUC values for each formulation and a ratio of geometric least-squares means with a 90% confidence interval.
These results do not establish a clinical effect in people with a disease. The registry describes the participants as healthy adults and does not report clinical outcomes. AUC is a pharmacokinetic measure, not a direct measure of symptom change, disease control, or patient benefit. The study’s stated purpose was to investigate relative bioavailability and pharmacokinetics.
The result also does not, on its own, establish that the formulations are equivalent or interchangeable. The registry does not report an equivalence margin, a prespecified decision rule, or the model details needed to evaluate the comparison against such a rule. The reported confidence interval quantifies uncertainty under the analysis used, but the record does not document all of the assumptions behind that analysis.
Interpretation is further limited by the absence of a clearly stated numerator for the reported ratio, although the registry identifies the two formulations in the contrast. The administered amounts differed: the free base capsule was 120 mg and the malate salt capsule was 100 mg. The record does not explain whether or how dose differences were accounted for in the comparison.
The crossover design allows both formulations to be given to participants in opposite sequences, separated by a minimum washout period of 14 days. However, the registry does not describe how period, sequence, or carryover were handled analytically. The result should therefore be understood as the registry’s reported contrast, not as a complete account of all design and model considerations.
The adverse-event figures are also descriptive. Zero serious adverse events and zero deaths were recorded in the listed groups, while other adverse events were reported for 10 participants in the malate salt group and 8 in the free base group. These observations do not establish absence of risk or support a broad safety comparison.
14. Why This Trial Matters Statistically
This trial illustrates how a randomized crossover design can be used to compare pharmacokinetic profiles. Rather than assigning participants to remain on only one formulation, the study randomized participants to receive both formulations in different orders. In general, that structure can make within-participant comparisons informative while requiring attention to period, sequence, and possible carryover.
It also shows why the summary measure and its scale matter. The primary endpoint is AUC from time zero to infinity, reported through geometric means and a ratio of geometric least-squares means. A ratio describes a relative contrast, while the confidence interval communicates uncertainty around that contrast. Interpreting either requires knowing the contrast direction and, for a model-based estimate, the analysis model. The registry does not explicitly state the numerator or provide the model details.
The record also highlights the difference between a posted result and a complete statistical analysis plan. It includes participant counts, endpoint summaries, a ratio, and a confidence interval, but does not report how period and sequence were handled, how incomplete profiles were treated, or whether multiplicity was addressed. Those details affect how fully readers can assess the analysis.
Finally, the study’s scope matters. It was a Phase 1 study in healthy adults, with pharmacokinetic outcomes as its focus. The results describe exposure comparisons in that setting. They should not be generalized into claims about clinical outcomes, and the adverse-event counts are descriptive rather than a definitive safety comparison.
15. 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 record leaves several details needed to assess the primary comparison unspecified. It does not report the statistical model, whether the analysis accounted for period or sequence, or how possible carryover was evaluated in this crossover study. Although it states a minimum washout period of 14 days, it does not describe how that interval was chosen.
The ratio of geometric least-squares means is reported as 87.63 with a 90% confidence interval from 78.273 to 98.111, but the analysis record does not explicitly identify the numerator. The record also does not provide the model method or a p-value. This limits the ability to reconstruct the contrast or evaluate the method underlying the interval.
The two formulations were administered at different dose amounts, 120 mg for free base and 100 mg for malate salt. The registry does not describe whether the comparison was dose-normalized or otherwise adjusted. It also does not give details of the concentration assay, AUC estimation, terminal extrapolation, or handling of values below measurement limits.
The endpoint summaries include 25 participants for malate salt and 26 for free base, compared with 26 enrolled. The record does not explain this accounting or describe missing-data rules and exclusions. It does not state whether all participants completed both periods or provide the number in each randomized sequence.
The registry does not report the original sample-size justification, multiplicity approach, interim analyses, or full statistical analysis plan. The reported adverse-event counts are also limited: serious events and deaths are listed, along with counts for other adverse events, but the record does not give event-level descriptions in this summary. These limitations constrain interpretation without changing the values that the registry reports.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults — NCT04472650.
- Registry record last updated 2024-10-26; status last verified 2024-10.
- Results first posted 2021-12-27.
- 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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19. Record Summary
NCT04472650 is a completed Phase 1, open-label, randomized crossover study sponsored by BeiGene. It enrolled 26 healthy adults and compared single doses of sitravatinib free base and malate salt capsule formulations in two dosing sequences, with a minimum washout period of 14 days.
The primary endpoint was AUC from time zero to infinity. The registry reports geometric mean values of 2525.0 h*ng/mL for malate salt and 2893.0 h*ng/mL for free base, and a ratio of geometric least-squares means of 87.63 with a 90% confidence interval from 78.273 to 98.111. The analysis record does not explicitly identify the ratio numerator or report the statistical method.
No serious adverse events or deaths were recorded in either listed group. Other adverse events were reported for 10 participants in the malate salt group and 8 in the free base group. Details of the analysis plan, missing-data handling, and multiplicity procedures are not reported in the registry record.