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 Dose Finding Safety Study of VAL201 in Cancer Patients (NCT02280317), a non-randomized phase 1, phase 2 study. The primary outcome is Dose-Limiting Toxicity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02280317 |
| Phase | Phase 1, Phase 2 |
| Condition | Stage III Prostate Carcinoma, Stage IV Prostate Carcinoma |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ValiRx Plc |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with advanced or metastatic prostate cancer and other advanced solid tumours. The listed conditions are Stage III and Stage IV prostate carcinoma. The registry record does not report how participants were distributed across diagnoses, or give further eligibility details. Enrollment is listed as 12.
Intervention
Participants received subcutaneous VAL201 in sequential dose cohorts. The listed dose levels were 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg and 4.0 mg/kg, followed by a cohort described as up to 8 mg/kg. At the highest cohort, escalation to 16 mg/kg after 3 cycles was a possibility subject to clinician decision; the record does not say whether that escalation occurred.
Comparator
There was no randomized control group. Allocation is recorded as non-randomized, and masking as none. The dose cohorts represent sequential exposure levels, not like-for-like treatment groups. Differences between their observed counts therefore cannot be interpreted as controlled estimates of the effect of one dose versus another.
Primary question
The primary endpoint was dose-limiting toxicity, measured as the number of participants with the event. The registry says this count was used to determine whether a maximum tolerated dose was obtained. The primary endpoint results are not reported in the registry record, so the record does not establish whether an MTD was identified.
3. Trial Design
This was a Phase I/II, non-randomized, unmasked, sequential dose-escalation study. The registry lists enrollment of 12 and a completed status. The recorded start was 2014-10, and primary completion was 2020-01-27. These dates describe the registry record and do not supply details about the timing of individual participants’ enrollment or follow-up.
VAL201 was administered by subcutaneous injection. The listed cohorts were 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg and up to 8 mg/kg. The description for the last cohort allows potential escalation to 16 mg/kg after 3 cycles according to clinician decision, with flexibility of dosing under the protocol. Whether any participant received that potential escalation is not reported in the registry record.
The sequential structure means participants were treated at dose levels in an escalation sequence rather than assigned randomly to competing doses. There was no masked treatment assignment and no concurrent control group. The registry describes the study as addressing safety and tolerability in patients with advanced or metastatic prostate cancer and other advanced solid tumours. Its secondary outcomes include pharmacokinetic measures of VAL201, Cmax and AUC 0-inf. The registry lists five outcome measures and zero analyses. It does not report the statistical analysis plan, rules used to move between dose levels, or results for the primary endpoint.
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: Interventional Study Model; Sequential Assignment -Dose Escalation sequential assignment-
Overall Study
| Stage | Cohort 1: 0.5 mg/kg | Cohort 2: 1.0 mg/kg | Cohort 3: 2.0 mg/kg | Cohort 4: 4.0 mg/kg | Cohort 5: Up to 8.0 mg/kg |
|---|---|---|---|---|---|
| STARTED | 1 | 1 | 3 | 5 | 2 |
| COMPLETED | 1 | 1 | 0 | 2 | 0 |
| NOT COMPLETED | 0 | 0 | 3 | 3 | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Cohort 1: 0.5 mg/kg | Cohort 2: 1 mg/kg | Cohort 3: 2 mg/kg | Cohort 4: 4 mg/kg | Cohort 5: up to 8 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 1 | 1 | 3 | 5 | 2 | 12 | |
| Age, Continuous | years | 70 (70 to 70) | 62 (62 to 62) | 76 (69 to 81) | 72.6 (60 to 84) | 73 (71 to 75) | 72.4 (60 to 84) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 3 | 5 | 2 | 12 |
| Race/Ethnicity, Customized: Race/Ethnicity – White | Participants | 1 | 1 | 2 | 4 | 2 | 10 |
| Race/Ethnicity, Customized: Race/Ethnicity – Black/African American | Participants | 0 | 0 | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Race/Ethnicity – Asian | Participants | 0 | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment: United Kingdom | participants | 1 | 1 | 3 | 5 | 2 | 12 |
| Stage of Cancer at Screening: Metastatic Prostate Cancer | Participants | 1 | 0 | 1 | 2 | 1 | 5 |
| Stage of Cancer at Screening: Locally Advanced Prostate Cancer | Participants | 0 | 1 | 2 | 3 | 1 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Dose-Limiting Toxicity, measured over The average timeframe is 18-26 weeks per subject.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is dose-limiting toxicity, with the unit recorded as participants. In practical statistical terms, this is a count of participants meeting the endpoint definition, rather than a continuous measurement such as a laboratory value. The registry description says the number of dose-limiting-toxicity events is used to determine whether a maximum tolerated dose is obtained. It gives an average timeframe of 18-26 weeks per subject.
In a dose-escalation study, this kind of endpoint is used to characterize tolerability as exposure levels increase. A decision about an MTD depends on how toxicity is defined, the observation period, the number of participants assessed at each dose, and the escalation decision rules. Those details are not fully reported in the registry record. In particular, the primary endpoint results and the operational definition of a dose-limiting toxicity are not reported. The adverse-event counts listed elsewhere in the record should not automatically be treated as primary endpoint counts: the record does not state which adverse events met the dose-limiting-toxicity definition or how the endpoint was adjudicated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety data give serious and other adverse-event counts for dose-cohort entries. For serious adverse events, the at-risk and affected counts are 1 and 0 for Cohort 1 at 0.5 mg/kg; 1 and 0 for Cohort 2 at 1.0 mg/kg; 3 and 0 for Cohort 3 at 2.0 mg/kg; 5 and 2 for Cohort 4 at 4.0 mg/kg; 1 and 1 for the Cohort 5 entry at 8 mg/kg; and 1 and 0 for the Cohort 5 entry at 4 mg/kg. These are descriptive counts, not estimates from a randomized comparison.
For other adverse events, the at-risk and affected counts are 1 and 1 in Cohort 1, 1 and 1 in Cohort 2, 3 and 3 in Cohort 3, 5 and 5 in Cohort 4, 1 and 1 in the Cohort 5 entry at 8 mg/kg, and 1 and 1 in the Cohort 5 entry at 4 mg/kg. The record lists zero deaths for each cohort entry. The serious-event counts and other-event counts are separate categories in the record; it does not explain their relationship or identify which events qualified as dose-limiting toxicities.
The listed leading serious-event terms include Hypertension at 100.0%, followed by Toxicity to various agents, Arrhythmia, Spinal Cord Compression and Sepsis at 20.0% each. The registry record does not specify the denominator or calculation context for these percentages, so they should be read as the values attached to the listed terms rather than converted into participant-level risks.
These data describe events recorded in a small, sequential study, but they do not by themselves establish a dose-response pattern. Cohorts differ in size, dose, and place in the escalation sequence; the record also contains two entries for Cohort 5 at different doses. Without random assignment, a comparison between cohorts can be affected by those design features and by clinical decisions about dose escalation. Most importantly, the primary dose-limiting-toxicity results are not reported in the registry record. Thus, these safety counts cannot establish whether an MTD was obtained or quantify uncertainty around that endpoint.
9. Statistical Methods Explained
What does a count endpoint represent?
The primary endpoint is recorded as a count of participants with dose-limiting toxicity. A count conveys how many participants met an endpoint definition within an assessed group. It is different from a continuous outcome, where each participant contributes a measurement on a numerical scale, and from a time-to-event outcome, where both event occurrence and timing are central. For a count to be interpretable, readers need the endpoint definition, the participants eligible for assessment, and the observation period. The record gives an average timeframe of 18-26 weeks per subject, but does not report the operational definition or the primary endpoint counts.
General statistical context: when counts are compared across groups, their denominators matter. A count from a group with more participants at risk is not directly comparable with the same count from a smaller group. Even ratios based on counts need clear definitions of the population and follow-up. No rate or risk calculation is warranted without those details and a stated analysis.
How does sequential escalation affect interpretation?
The study is described as sequential and non-randomized. In a sequential dose-escalation design, movement across dose levels is part of the study process. Later cohorts may receive a higher dose because of earlier clinical and safety decisions, rather than because participants were randomly assigned to a dose. This structure is suited to studying dose levels in sequence, but it does not make the cohorts equivalent comparison groups.
General statistical context: randomization helps balance measured and unmeasured prognostic characteristics, on average, across treatment groups. Without randomization, observed differences may reflect who entered each cohort, how dose decisions were made, or other changes during the study, as well as dose. The registry records no masking, so treatment assignment was not masked. It does not report the detailed escalation algorithm, decision thresholds, or any interim analysis procedures. The Cohort 5 description permits escalation to 16 mg/kg after 3 cycles at clinician discretion; the record does not confirm that this occurred.
What can the adverse-event counts tell readers?
The adverse-event record lists counts at risk and counts affected, separately for serious and other events, within each cohort entry. These are descriptive safety data. They can identify which event categories were recorded and how many participants were reported as affected in each entry. They do not show a controlled difference between doses. The record does not state whether every event was counted once per participant, whether recurrent events were handled separately, or how event severity and attribution were determined beyond the serious-event grouping.
General statistical context: sparse counts carry substantial uncertainty. When few participants are observed, a count can change meaningfully with the outcome of a single participant, and estimates of event frequency are imprecise. A confidence interval, when reported, describes the range of values compatible with the data under a specified method and assumptions; it is not a guarantee that the true value lies within that range. The registry record does not report confidence intervals for these counts or a statistical comparison across dose cohorts.
What is missing from the statistical reporting?
The registry lists zero analyses. The primary endpoint results, analysis populations, handling of missing observations, and statistical analysis plan are not reported in the registry record. It is therefore not possible to determine from this record whether the primary endpoint used all enrolled participants, only participants who completed an observation period, or another defined population. Nor is it possible to assess whether any participants were excluded from an analysis or how incomplete follow-up was handled.
General statistical context: analysis populations should be defined before interpreting results. In a randomized trial, an intention-to-treat population commonly retains participants in their assigned groups, while other populations may be based on treatment received or protocol adherence. In a non-randomized dose-escalation study, the population definitions still need to specify who was included at each dose and who was evaluable for toxicity. Those conventions cannot be assumed for this study because the registry does not report them.
The registry lists secondary pharmacokinetic outcomes of Cmax and AUC 0-inf, but does not report their results or analysis methods. It also does not report a multiplicity strategy for interpreting multiple outcomes. General statistical context: evaluating several endpoints can increase the chance of a misleading positive finding if each is assessed independently without regard to the number of questions being tested. Whether adjustment is appropriate depends on the study goals and analysis plan; no such plan is reported in the registry record.
Finally, no inferential result for the primary endpoint is available in this record. There is no reported estimate, confidence interval, or hypothesis test to support a precision assessment. The adverse-event counts should consequently be treated as descriptive registry data, not as a complete statistical analysis of dose-limiting toxicity, safety, or pharmacokinetics.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including the primary dose-limiting-toxicity endpoint and secondary pharmacokinetic measures of Cmax and AUC 0-inf. It reports zero analyses. A multiplicity strategy for handling more than one outcome or comparison is not reported in the registry record. Without that strategy and the analysis results, there is no basis for interpreting a collection of statistical tests or for judging whether any adjustment was used.
General statistical context: multiplicity arises when several outcomes, time points, subgroups, or comparisons are assessed. If each is treated as an independent opportunity to declare a finding, the chance of at least one apparently notable result can increase. Methods to address this depend on whether outcomes are confirmatory or exploratory and on the prespecified analysis plan. No such distinctions or plan are reported.
Missing-data procedures and analysis populations are also not reported in the registry record. The record does not say how incomplete endpoint observations, withdrawals, or participants not evaluable for toxicity were handled. The listed average timeframe of 18-26 weeks per subject does not establish that every participant completed that period. The record does not give participant-level follow-up or reasons for missing observations. It also does not define an evaluable population for the primary endpoint. Consequently, the reported adverse-event counts can be described as recorded, but their completeness and the handling of any unavailable data cannot be assessed from the registry record.
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 |
|---|---|---|---|
| Cohort 1: 0.5 mg/kg | 0 | 1 | 0.0% |
| Cohort 2: 1.0 mg/kg | 0 | 1 | 0.0% |
| Cohort 3: 2.0 mg/kg | 0 | 3 | 0.0% |
| Cohort 4: 4.0 mg/kg | 2 | 5 | 40.0% |
| Cohort 5: up to 8 mg/kg (8 mg/kg) | 1 | 1 | 100.0% |
| Cohort 5: up to 8 mg/kg (4 mg/kg) | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1: 0.5 mg/kg | 0 of 1 |
| Cohort 2: 1.0 mg/kg | 0 of 1 |
| Cohort 3: 2.0 mg/kg | 0 of 3 |
| Cohort 4: 4.0 mg/kg | 0 of 5 |
| Cohort 5: up to 8 mg/kg (8 mg/kg) | 0 of 1 |
| Cohort 5: up to 8 mg/kg (4 mg/kg) | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1: 0.5 mg/kg | 1 of 1 |
| Cohort 2: 1.0 mg/kg | 1 of 1 |
| Cohort 3: 2.0 mg/kg | 3 of 3 |
| Cohort 4: 4.0 mg/kg | 5 of 5 |
| Cohort 5: up to 8 mg/kg (8 mg/kg) | 1 of 1 |
| Cohort 5: up to 8 mg/kg (4 mg/kg) | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1: 0.5 mg/kg | Cohort 2: 1.0 mg/kg | Cohort 3: 2.0 mg/kg | Cohort 4: 4.0 mg/kg | Cohort 5: up to 8 mg/kg (8 mg/kg) | Cohort 5: up to 8 mg/kg (4 mg/kg) |
|---|---|---|---|---|---|---|---|
| Hypertension | Vascular disorders | 0 of 1 | 0 of 1 | 0 of 3 | 0 of 5 | 1 of 1 | 0 of 1 |
| Toxicity to various agents | Injury, poisoning and procedural complications | 0 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 0 of 1 | 0 of 1 |
| Arrhythmia | Cardiac disorders | 0 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 0 of 1 | 0 of 1 |
| Spinal Cord Compression | Nervous system disorders | 0 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 0 of 1 | 0 of 1 |
| Sepsis | Infections and infestations | 0 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 0 of 1 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1: 0.5 mg/kg | Cohort 2: 1.0 mg/kg | Cohort 3: 2.0 mg/kg | Cohort 4: 4.0 mg/kg | Cohort 5: up to 8 mg/kg (8 mg/kg) | Cohort 5: up to 8 mg/kg (4 mg/kg) |
|---|---|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 1 | 0 of 1 | 3 of 3 | 3 of 5 | 0 of 1 | 0 of 1 |
| Injection site reaction | General disorders | 1 of 1 | 1 of 1 | 2 of 3 | 0 of 5 | 1 of 1 | 1 of 1 |
| Injection site rash | General disorders | 0 of 1 | 0 of 1 | 0 of 3 | 4 of 5 | 0 of 1 | 1 of 1 |
| Injection site pain | General disorders | 0 of 1 | 0 of 1 | 1 of 3 | 2 of 5 | 1 of 1 | 1 of 1 |
| Dizziness | Nervous system disorders | 0 of 1 | 1 of 1 | 0 of 3 | 1 of 5 | 1 of 1 | 1 of 1 |
| Dyspepsia | Gastrointestinal disorders | 1 of 1 | 0 of 1 | 0 of 3 | 3 of 5 | 0 of 1 | 0 of 1 |
| Hypertension | Vascular disorders | 0 of 1 | 0 of 1 | 1 of 3 | 0 of 5 | 0 of 1 | 1 of 1 |
| Injection site erythema | General disorders | 0 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 1 of 1 | 0 of 1 |
| Headache | Nervous system disorders | 0 of 1 | 0 of 1 | 0 of 3 | 2 of 5 | 0 of 1 | 0 of 1 |
| Diarrhoea | Gastrointestinal disorders | 1 of 1 | 0 of 1 | 0 of 3 | 1 of 5 | 0 of 1 | 0 of 1 |
Serious events with the highest arm-level rate: hypertension (100.0%), toxicity to various agents (20.0%), arrhythmia (20.0%), spinal cord compression (20.0%), sepsis (20.0%).
The serious adverse-event figures are counts, listed with the number at risk in each cohort entry. In the order of the entries, the serious-event counts are 0 among 1 at risk, 0 among 1, 0 among 3, 2 among 5, 1 among 1, and 0 among 1. The other-adverse-event counts are 1 among 1, 1 among 1, 3 among 3, 5 among 5, 1 among 1, and 1 among 1. The registry lists zero deaths in every entry.
These are small descriptive groups, and the dose cohorts were not randomized comparison arms. Their counts should not be treated as evidence that one dose is safer or less safe than another. The serious-event terms include Hypertension at 100.0%, and Toxicity to various agents, Arrhythmia, Spinal Cord Compression and Sepsis at 20.0% each. The percentage denominator and calculation context are not reported in the registry record. Serious adverse events are not necessarily the same as dose-limiting toxicities; the record does not identify which events met the primary endpoint definition.
12. What the Result Does, and Does Not, Mean
The record establishes that VAL201 was studied in a completed, sequential Phase I/II dose-escalation study with enrollment listed as 12. It describes subcutaneous dosing across several cohorts and provides serious and other adverse-event counts, along with listed serious-event terms. These details allow a reader to understand the study’s broad design and the kinds of safety information recorded.
The record does not report the primary endpoint results. Therefore, it cannot show from the registry whether dose-limiting toxicity occurred according to the study’s endpoint definition, whether an MTD was identified, or how precise any estimate would be. Although the registry includes adverse-event counts, those counts are not a substitute for the primary endpoint analysis. The record does not say which recorded events met the dose-limiting-toxicity definition.
The design also limits comparative interpretation. The study was non-randomized, unmasked and sequential, with no control group. The cohort counts are descriptive and do not establish that differences between dose entries were caused by dose. The listed adverse-event figures should not be read as a randomized estimate of comparative safety.
The registry identifies pharmacokinetic outcomes, but does not report their results. It also does not report efficacy results, a detailed analysis plan, analysis populations, or missing-data procedures. Accordingly, this record alone cannot establish an efficacy effect, a definitive safety profile, or the balance of benefits and harms. A completed status indicates the study’s recorded status; it does not supply the missing endpoint results or resolve uncertainty about how the data were analyzed.
13. Why This Trial Matters Statistically
This study is statistically notable as a sequential dose-escalation design rather than a randomized treatment comparison. Its central question is about dose-limiting toxicity and whether an MTD was obtained. That makes clear endpoint definitions, observation windows, escalation rules and evaluable-population criteria important to interpretation. The registry describes the endpoint’s purpose and gives an average timeframe of 18-26 weeks per subject, but does not report the primary endpoint results or several details needed to assess the analysis.
The cohort structure also illustrates why safety counts need context. The registry lists at-risk counts that vary across dose entries, and the entries are not randomized arms. A simple comparison of their event counts would not account for cohort size, sequence, clinician decisions or possible differences in who was assessed. The potential clinician-directed escalation in the final cohort makes the actual exposure history particularly relevant, but whether that escalation occurred is not reported.
For clinical researchers and biostatisticians, the record demonstrates the distinction between descriptive safety listings and a complete statistical result. Counts can show what the registry records, but they do not provide an uncertainty interval, a controlled dose contrast, or an answer to the primary endpoint question. The absence of reported analyses and analysis-population details further limits reproducibility and assessment of missingness. These are not merely presentation details: they determine what population and estimand a result would describe. The study’s stated purpose can be understood, while its primary statistical conclusion cannot be recovered from 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 main trial-specific limitation is that the registry record does not report the primary dose-limiting-toxicity results, even though this is the stated primary endpoint used to determine whether an MTD was obtained. The definition of dose-limiting toxicity and the detailed decision rules for escalation are also not reported. The possible escalation to 16 mg/kg after 3 cycles depended on clinician decision, but the record does not say whether it occurred.
Interpretation of the adverse-event entries is limited by the non-randomized, sequential design and the absence of masking. There is no control group, and the dose cohorts should not be treated as directly comparable groups. The record presents two Cohort 5 entries at different doses, but does not provide further explanation of their relationship. It does not give participant-level exposure or follow-up, or identify which serious events also met the primary endpoint.
The registry does not report participant characteristics beyond the listed conditions, the distribution of diagnoses, reasons for missing observations, analysis populations, or missing-data methods. Although the average timeframe is 18-26 weeks per subject, completion of that period for each participant is not documented. Statistical analysis methods, uncertainty estimates, multiplicity handling and pharmacokinetic results are not reported. These omissions prevent a full assessment of precision, completeness, and the intended interpretation of the endpoint.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dose Finding Safety Study of VAL201 in Cancer Patients — NCT02280317.
- Registry record last updated 2021-11-08; status last verified 2021-10.
- Results first posted 2021-11-08.
- 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
NCT02280317 is recorded as a completed Phase I/II, non-randomized, unmasked, sequential dose-escalation study of subcutaneous VAL201 in patients with advanced or metastatic prostate cancer and other advanced solid tumours. Enrollment is listed as 12. The registry describes dose cohorts from 0.5 mg/kg through a cohort of up to 8 mg/kg, with potential clinician-directed escalation to 16 mg/kg after 3 cycles.
The primary endpoint is dose-limiting toxicity, measured as participants, with an average timeframe of 18-26 weeks per subject. Secondary outcomes include Cmax and AUC 0-inf. Serious and other adverse-event counts, and leading serious-event terms, are recorded by cohort entry. The registry lists five outcome measures and zero analyses, but does not report the primary endpoint results, pharmacokinetic results, statistical analysis plan, or analysis populations. The posted safety counts are descriptive and do not provide a randomized comparison between doses.