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 Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias (NCT00920140), a non-randomized phase 2 study. The primary outcome is Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00920140 |
| Phase | Phase 2 |
| Condition | Cancer |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 97 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
People with relapsed or refractory leukemias were eligible for the study. The registry describes the all-treated safety population as participants who received at least one dose of study medication. The posted safety results include groups receiving GSK1120212 at two dose levels.
Intervention
The intervention was the oral MEK inhibitor GSK1120212. The study description identifies continuous daily dosing and says dose and schedule could be altered in light of emerging pharmacokinetic, pharmacodynamic, and tolerability data.
Comparator
There was no randomized control group. The posted results separate participants by dose, but those groups are not a like-for-like control comparison. Differences between them cannot be interpreted as an unbiased estimate of a dose effect.
Primary question
The primary outcome counts participants with any adverse event or serious adverse event by dose, from the start of study drug through the final study visit, up to approximately 407 days. The endpoint is a safety measure, not a randomized test of clinical benefit.
The registry describes the study as an open-label dose-escalation Phase I/II investigation of safety, pharmacokinetics, pharmacodynamics, and clinical activity. Its stated aims included identifying a maximum tolerated dose and a recommended Phase II dose, then evaluating clinical activity in Phase II. The posted primary outcome is specifically a count of participants with adverse events by dose. The record does not report a treatment-versus-control question or a randomized efficacy comparison. Overall survival is listed among secondary outcomes, but its results are not included in the registry record described for this analysis. Consequently, the primary safety counts address whether participants experienced reported events within each dose group; they do not, by themselves, establish whether the drug caused an event or whether one dose is safer than another.
3. Trial Design
NCT00920140 is described in the registry as an open-label, dose-escalation Phase I/II study of GSK1120212 in people with relapsed or refractory leukemias. The phase field lists PHASE2, while the study title and description characterize the investigation as Phase I/II. The registry lists non-randomized allocation, no masking, and a single-group model. The posted safety results are organized by dose, but there was no randomized assignment to those dose groups. The record lists enrollment of 97 participants and status as completed.
The study description says that Phase I dose escalation was intended to identify the maximum tolerated dose and recommended Phase II dose. It describes continuous daily dosing, with a loading dose before maintenance dosing at the initiation of treatment. The dose and schedule could be altered in response to emerging pharmacokinetic, pharmacodynamic, and tolerability data. In Phase II, the description says a dose selected in Phase I would be evaluated for safety, pharmacokinetics, pharmacodynamics, and clinical activity. These are stated aims and design features, not evidence that a particular dose was selected or that a clinical effect was established.
The safety population is defined as all treated participants: anyone who received at least one dose of study medication. The registry notes that one Phase II participant was incorrectly dosed, receiving less than 2 mg (0.5 mg), and that 6 participants receiving GSK1120212 less than 2 mg once daily were analyzed. The other posted dose group is GSK1120212 2 mg once daily. This dose-based presentation does not create a control group. Because dose assignment was non-randomized and the study was open-label, the groups may differ in ways that affect the observed event counts. The registry record does not report the allocation procedure, a statistical analysis plan, or a sample-size justification.
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 is a Phase I/II study. Phase I is a dose escalation phase in participants with relapsed or refractory leukaemias to identify the recommended dose of GSK1120212 for Phase II. Phase II further evaluates the safety and efficacy of the recommended dose.
Phase 1 (Dose Escalation)
| Stage | GSK1120212 < 2 mg OD | GSK1120212 2 mg OD | Cohort 1: AML/MDS With RAS Mutation | Cohort 2: AML/MDS/CMML With RAS wt/Unknown | Cohort 3: CMML With RAS Mutation |
|---|---|---|---|---|---|
| STARTED | 5 | 9 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 5 | 9 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | GSK1120212 < 2 mg OD | GSK1120212 2 mg OD | Cohort 1: AML/MDS With RAS Mutation | Cohort 2: AML/MDS/CMML With RAS wt/Unknown | Cohort 3: CMML With RAS Mutation |
|---|---|---|---|---|---|
| Adverse Event | 3 | 3 | 0 | 0 | 0 |
| Lack of Efficacy | 2 | 4 | 0 | 0 | 0 |
| Withdrawal by Subject | 0 | 2 | 0 | 0 | 0 |
Phase 2
| Stage | GSK1120212 < 2 mg OD | GSK1120212 2 mg OD | Cohort 1: AML/MDS With RAS Mutation | Cohort 2: AML/MDS/CMML With RAS wt/Unknown | Cohort 3: CMML With RAS Mutation |
|---|---|---|---|---|---|
| STARTED | 0 | 0 | 50 | 22 | 11 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 50 | 22 | 11 |
Reasons for not completing this period:
| Reason | GSK1120212 < 2 mg OD | GSK1120212 2 mg OD | Cohort 1: AML/MDS With RAS Mutation | Cohort 2: AML/MDS/CMML With RAS wt/Unknown | Cohort 3: CMML With RAS Mutation |
|---|---|---|---|---|---|
| Adverse Event | 0 | 0 | 14 | 2 | 3 |
| Lack of Efficacy | 0 | 0 | 29 | 14 | 5 |
| Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Physician Decision | 0 | 0 | 3 | 3 | 2 |
| Withdrawal by Subject | 0 | 0 | 4 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | GSK1120212 <2 mg OD | GSK1120212 2 mg OD | Cohort 1: AML/MDS With RAS Mutation | Cohort 2: AML/MDS/CMML With RAS wt/Unknown | Cohort 3: CMML With RAS Mutation | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 5 | 9 | 50 | 22 | 11 | 97 | |
| Age, Continuous | Years | 70.4 (SD 15.71) | 60.2 (SD 15.86) | 65.6 (SD 10.71) | 59.6 (SD 18.89) | 67.7 (SD 6.87) | 64.2 (SD 13.69) |
| Sex: Female, Male: Female | Participants | 4 | 2 | 22 | 7 | 6 | 41 |
| Sex: Female, Male: Male | Participants | 1 | 7 | 28 | 15 | 5 | 56 |
| Race/Ethnicity, Customized: African American/African Heritage | Participants | 1 | 0 | 5 | 2 | 0 | 8 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 4 | 9 | 40 | 18 | 9 | 80 |
| Race/Ethnicity, Customized: Asian - Central/South Asian Heritage | Participants | 0 | 0 | 0 | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Asian - Japanese Heritage | Participants | 0 | 0 | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Asian - South East Asian Heritage | Participants | 0 | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Missing | Participants | 0 | 0 | 4 | 0 | 1 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose, measured over From the start of the study drug until the final study visit (up to approximately 407 days).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with any adverse event or serious adverse event, reported by dose. An adverse event is defined as an untoward medical occurrence temporally associated with use of a medicinal product, whether or not it is considered related to that product. A serious adverse event is defined by outcomes such as death, a life-threatening event, hospitalization or prolonged hospitalization, disability or incapacity, congenital anomaly or birth defect, or possible drug-induced liver injury.
The registry specifies that safety was evaluated in participants who received at least one dose. The outcome timeframe runs from the start of study drug until the final study visit, up to approximately 407 days. Counting participants with events is a direct way to describe how many people in each dose group had at least one event in the observed period. It is useful in a safety-focused study because it gives a participant-level count rather than a count of repeated event episodes. However, a count does not convey the timing, duration, recurrence, severity distribution, or attribution of every event. Nor does an event’s occurrence establish that study medication caused it. The registry record does not report a separate causal assessment for the primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts describe events among treated participants in two dose groups. In the group receiving GSK1120212 less than 2 mg once daily, 2 of 6 participants had a serious adverse event, and 6 of 6 had an other adverse event. In the 2 mg once-daily group, 64 of 91 participants had a serious adverse event, and 90 of 91 had an other adverse event. These are descriptive counts within the groups, not results from a randomized comparison.
The groups should not be read as if one were a control arm for the other. The study used non-randomized allocation, and the registry specifically cautions that the arms are not a like-for-like control comparison. Participants at different doses may have differed in characteristics, clinical circumstances, exposure, or duration of observation; details sufficient to assess these possibilities are not reported in the registry record. The posted counts therefore cannot isolate the effect of dose or establish whether GSK1120212 caused the events.
The registry lists pneumonia at 18.7%, urinary tract infection at 16.7%, neutropenia at 16.7%, febrile neutropenia at 16.5%, sepsis at 7.7%, and bacteraemia at 4.4% among the leading serious event terms. These percentages are event-term summaries, not an additional randomized comparison. Their denominators and the method used to select or summarize terms are not reported in the registry record. A participant may also experience more than one event, so a list of event terms should not be treated as a count of distinct people unless the record says so.
No confidence intervals, hypothesis tests, or adjusted comparisons are reported in the registry record. Without a measure of uncertainty, the precision of the group-level estimates cannot be assessed from these counts alone. Even if an unadjusted comparison were calculated from the posted summaries, it would not remove the limitations created by non-randomized dose assignment. The registry record lists overall survival as a secondary outcome, but no corresponding survival result is included in the registry record for this analysis. The safety findings should therefore be read as descriptive observations in the treated population, not as proof of comparative safety or clinical efficacy.
9. Statistical Methods Explained
What does a participant count describe?
The primary outcome is a count of participants who experienced an adverse event or serious adverse event during the stated observation period. This type of outcome focuses on whether each person had at least one qualifying event. It is different from counting every event episode: a person with repeated episodes may still contribute once to a participant count. The registry record presents serious and other adverse event counts by dose, but does not report how repeated events were handled in every outcome summary.
As a general statistical concept, a proportion is the number of participants with an event relative to the number in the group being described. The reported group counts can be read alongside their group sizes, but they do not explain why events occurred. Event status also does not by itself establish causation. Clinical context, timing, attribution, and other information are needed to interpret individual safety events; those details are not fully available in the registry record.
Why does non-randomized allocation matter?
Random assignment is used in comparative trials to balance, on average, measured and unmeasured characteristics between groups. This study is listed as non-randomized, with no masking and a single-group model. Dose groups are therefore descriptive groups, not randomized treatment and control arms. General statistical reasoning cautions that differences between non-randomized groups may reflect differences in participants or their circumstances as well as dose. An unadjusted comparison cannot separate these explanations. The registry record does not report an adjustment method or a formal comparison of the dose groups.
The study description says that dose and schedule could change in response to emerging pharmacokinetic, pharmacodynamic, and tolerability information. That adaptive dose-escalation context is part of the stated design. It does not, on its own, reveal the actual decision rules used, how participants were assigned to doses, or how the final analysis handled those decisions. Those details are not reported in the registry record.
How should uncertainty be understood?
A confidence interval is a general statistical tool for expressing the precision of an estimate. A narrower interval indicates greater precision under the method’s assumptions; a wider interval indicates more uncertainty. The registry record does not report confidence intervals for these safety counts. It also does not report hypothesis tests or adjusted estimates for a dose comparison. Thus, the counts describe the observed participants, but the precision of any estimate of event frequency is not quantified in the reported information.
General statistical methods for participant-level binary outcomes can compare event proportions, but such methods require attention to the design, group sizes, and analysis assumptions. A model may also be needed when the goal is to adjust for participant characteristics or account for other features of the data. No such method is reported in the registry record. A recalculated comparison, if presented elsewhere, would be a simple unadjusted re-calculation from posted summary statistics, not a replacement for the sponsor’s own analysis. If a discrepancy is identified, the sponsor’s own analysis takes precedence.
What do the planning illustrations mean?
The planning illustrations are based on the observed effect and are described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They consider the effect to detect as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm for 80% power or another stated power level; time-to-event illustrations use total events. These are general planning assumptions, not the design justification for this study. The registry record does not report its own sample-size justification. Planning estimates are not observed power and do not change the interpretation of the trial’s non-randomized safety groups.
Over-dispersion is a general concern when count data vary more than a simple statistical model assumes. It can make standard errors too small if the model does not allow for that extra variability. The primary outcome is a participant count with an event rather than a repeated-event rate, and the registry does not report a model for repeated counts or an over-dispersion assessment. It would therefore be inappropriate to claim that such an adjustment was used.
What cannot be inferred from the posted method details?
The registry record does not report the analysis plan, interim analyses, missing-data methods, confidence intervals, or hypothesis tests for the primary safety outcome. It also does not report methods for any subgroup or adjusted analyses. Without those details, the result should be treated as a descriptive account of the posted counts. The design and reporting information does not support a causal interpretation of differences between dose groups, nor does it provide a basis for claiming that a treatment effect was established.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and identifies pharmacokinetic measures and overall survival among the secondary outcomes. The registry record does not report how multiple outcomes were handled statistically, whether any outcomes were designated for formal hypothesis testing, or whether a multiplicity adjustment was planned. When many outcomes are tested, the chance of at least one apparently notable result can increase; this is a general statistical consideration, not a claim about a particular analysis in this study.
The registry record does not report the number of missing observations for the primary safety outcome, a missing-data method, or a sensitivity analysis. The safety population is defined as participants who received at least one dose, and the primary outcome timeframe extends through the final study visit, up to approximately 407 days. The description does not specify how incomplete follow-up or an unavailable event assessment was handled. A participant without a reported event should not automatically be assumed to have completed all follow-up unless that is established in the analysis details.
The record lists no analysis entries. It does not report a statistical analysis plan, interim analyses, or methods for adjusting the safety results for other participant characteristics. Consequently, the posted counts can be described within the treated population, but readers cannot determine from the registry record whether missingness, multiplicity, or adjustment procedures affected an inferential analysis. These reporting gaps limit interpretation; they are not evidence that a particular method was or was not used outside what the registry reports.
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 |
|---|---|---|---|
| GSK1120212 <2 mg OD | 2 | 6 | 33.3% |
| GSK1120212 2 mg OD | 64 | 91 | 70.3% |
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 |
|---|---|
| GSK1120212 <2 mg OD | 6 of 6 |
| GSK1120212 2 mg OD | 90 of 91 |
Most frequent serious adverse event terms
| Event term | Organ system | GSK1120212 <2 mg OD | GSK1120212 2 mg OD |
|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 6 | 17 of 91 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 6 | 15 of 91 |
| Sepsis | Infections and infestations | 0 of 6 | 7 of 91 |
| Urinary tract infection | Infections and infestations | 1 of 6 | 4 of 91 |
| Bacteraemia | Infections and infestations | 0 of 6 | 4 of 91 |
| Cellulitis | Infections and infestations | 0 of 6 | 4 of 91 |
| Anaemia | Blood and lymphatic system disorders | 0 of 6 | 4 of 91 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 6 | 4 of 91 |
| Staphylococcal infection | Infections and infestations | 0 of 6 | 3 of 91 |
| Atrial fibrillation | Cardiac disorders | 0 of 6 | 3 of 91 |
Most frequent non-serious adverse event terms
| Event term | Organ system | GSK1120212 <2 mg OD | GSK1120212 2 mg OD |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 5 of 6 | 43 of 91 |
| Nausea | Gastrointestinal disorders | 3 of 6 | 24 of 91 |
| Fatigue | General disorders | 2 of 6 | 22 of 91 |
| Oedema peripheral | General disorders | 3 of 6 | 21 of 91 |
| Pyrexia | General disorders | 3 of 6 | 21 of 91 |
| Rash | Skin and subcutaneous tissue disorders | 0 of 6 | 24 of 91 |
| Alanine aminotransferase increased | Investigations | 0 of 6 | 21 of 91 |
| Aspartate aminotransferase increased | Investigations | 2 of 6 | 19 of 91 |
| Vomiting | Gastrointestinal disorders | 2 of 6 | 18 of 91 |
| Anaemia | Blood and lymphatic system disorders | 2 of 6 | 18 of 91 |
Serious events with the highest arm-level rate: pneumonia (18.7%), urinary tract infection (16.7%), neutropenia (16.7%), febrile neutropenia (16.5%), sepsis (7.7%).
For GSK1120212 less than 2 mg once daily, the registry reports serious adverse events in 2 of 6 participants and other adverse events in 6 of 6 participants. For GSK1120212 2 mg once daily, it reports serious adverse events in 64 of 91 participants and other adverse events in 90 of 91 participants. These counts use the registry’s treated safety population and should be read as descriptions of the participants in each dose group.
The registry also lists pneumonia (18.7%), urinary tract infection (16.7%), neutropenia (16.7%), febrile neutropenia (16.5%), sepsis (7.7%), and bacteraemia (4.4%) among the leading serious event terms. The record does not specify in the registry record the denominator or counting method for these term percentages. They should not be added together or interpreted as percentages of distinct participants without that information. The death counts are not reported in the registry record.
Because dose assignment was non-randomized, the group counts do not establish that dose caused a difference in event frequency. An adverse event is not necessarily considered related to the study drug, by the registry definition. No confidence intervals or adjusted comparisons are reported in the registry record.
12. What the Result Does, and Does Not, Mean
The results give a descriptive account of reported adverse events among participants who received at least one dose of GSK1120212. They distinguish serious adverse events and other adverse events by dose group and list several leading serious event terms. This information can help readers understand what safety events were recorded during the study’s observation period, which ran from treatment start until the final study visit, up to approximately 407 days.
The counts do not establish that GSK1120212 caused any particular event. The registry’s definition of an adverse event explicitly includes events whether or not they are considered related to the medicinal product. The posted information also does not show whether the dose groups had comparable participants, and the registry identifies the study as non-randomized. The groups therefore cannot be used as randomized alternatives for estimating a causal dose effect.
The primary outcome is a safety measure, not a measure of clinical benefit. Although the study description states that Phase II would assess clinical activity and the secondary outcomes include overall survival by cohort, the registry entries summarized for this analysis do not include those results. No conclusion about efficacy or survival can be drawn from the safety counts.
Precision is also uncertain because the registry record does not report confidence intervals or statistical tests for the primary outcome. The event counts are informative as observations in the analyzed population, but they do not quantify uncertainty around an underlying event frequency. Nor do they reveal the full clinical course of each event, its recurrence, or its attributed cause. The appropriate interpretation is limited to the recorded safety experience and the stated limitations of the study design and reporting.
13. Why This Trial Matters Statistically
This study illustrates why safety counts need to be interpreted in the context of trial design. The registry reports adverse events by dose, but identifies the study as non-randomized and single-group. Dose groups may appear side by side in a results display, yet that arrangement does not make them randomized comparison arms. Recognizing this distinction prevents descriptive differences from being mistaken for evidence of a causal dose effect.
The registry also separates the primary safety question from the broader study aims. Its stated aims included pharmacokinetics, pharmacodynamics, dose selection, and clinical activity, while the primary outcome counts participants with adverse events or serious adverse events. These are related parts of a study but answer different questions. A safety count cannot substitute for a clinical activity or survival result.
Finally, the record demonstrates the importance of reporting the analysis process as well as the observed counts. Confidence intervals, hypothesis tests, missing-data handling, multiplicity procedures, and a statistical analysis plan are not reported in the registry record. Without these details, readers can describe the observed data but cannot assess inferential precision or determine how analytic choices affected conclusions. Clear separation of design, observed outcomes, and unreported methods is central to responsible interpretation of clinical trial results.
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 is the non-randomized design. The dose groups are not like-for-like controls, so differences in their event counts cannot be attributed to dose alone. The study is open-label and has no masking, according to the registry. The registry entries do not describe how participants entered each dose group or provide enough information to evaluate whether the groups differed in baseline characteristics or clinical circumstances.
The safety results are participant counts, which do not describe the full pattern of event episodes, their timing, duration, recurrence, or relatedness to treatment. The registry lists leading serious event terms and percentages, but the denominator and method for those percentages are not reported in the registry record. Death counts are also not reported in the registry record.
Statistical uncertainty is not quantified in the posted information: confidence intervals, hypothesis tests, and adjusted comparisons are not reported in the registry record. The record also does not report missing-data handling, multiplicity procedures, interim analyses, or the study’s sample-size justification. The safety population is defined as treated participants, but the details of follow-up completeness are not reported. These limitations restrict the results to a descriptive account of events in the analyzed groups and make comparative or causal conclusions unsupported by the registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias — NCT00920140.
- Registry record last updated 2014-04-02; status last verified 2014-03.
- Results first posted 2014-02-28.
- 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
NCT00920140 is a completed, open-label, non-randomized study of GSK1120212 in people with relapsed or refractory leukemias. The registry describes a dose-escalation Phase I/II study, while its phase field lists PHASE2. Enrollment was 97. The primary outcome counts participants with any adverse event or serious adverse event by dose, from the start of study drug through the final study visit, up to approximately 407 days.
The posted safety groups are GSK1120212 less than 2 mg once daily and GSK1120212 2 mg once daily. The registry reports serious and other adverse event counts for each group, along with leading serious event terms. Because dose allocation was non-randomized, these groups are not a like-for-like control comparison. The registry record does not report confidence intervals, hypothesis tests, a statistical analysis plan, missing-data methods, or a sample-size justification. The results are best understood as descriptive safety observations, not as proof of causation, comparative safety, or clinical efficacy.