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 Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate (NCT01523002), a randomized phase 1 study. The primary outcome is World Health Organization (WHO) Treatment Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01523002 |
| Phase | Phase 1 |
| Condition | Malaria |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 56 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medicines for Malaria Venture |
| Results posted | Yes |
2. Clinical Question
The registry record describes a study with two related aims in healthy volunteers: evaluating a possible interaction between metoprolol, a CYP2D6 substrate, and pyronaridine-artesunate; and assessing the safety of repeating a 3-day pyronaridine-artesunate regimen after follow-up intervals of 60 or 90 days. The stated primary outcome is the number of participants with World Health Organization (WHO) treatment-emergent adverse events over 140 days.
Population
Healthy volunteers enrolled in a phase 1 study. The registry record lists 56 participants overall.
Intervention
Pyronaridine-artesunate, with metoprolol included in the drug-interaction arm. The redosing study evaluated repeat 3-day regimens.
Comparator
The registry describes a randomized, parallel-group study. One arm involved 90-day redosing and the other 60-day redosing; a placebo or untreated comparator is not reported in the registry record.
Primary question
What treatment-emergent adverse events occurred during the 140-day assessment period, and what does the record show about safety after redosing?
The drug-interaction objective was to evaluate any interaction between metoprolol and pyronaridine-artesunate. The redosing objective concerned safety after a repeated regimen, rather than a comparison of treatment benefit for malaria. The posted primary outcome is an adverse-event count, not a measure of antimalarial efficacy.
The registry record does not report a single stated primary comparison that combines the drug-interaction and redosing questions. It also does not report detailed criteria for volunteer eligibility, or how the recorded safety outcome was intended to distinguish events related to one regimen from those related to another. Those omissions limit how specifically the clinical question can be reconstructed.
3. Trial Design
This was a phase 1, randomized, open-label, parallel-group study listed as completed. The registry record reports enrollment of 56 healthy volunteers and lists Malaria as the condition. Medicines for Malaria Venture is identified as the sponsor. The study start is recorded as 2012-01 and primary completion as 2012-07.
The trial combined a drug-interaction study and a redosing study. In the drug-interaction arm, participants were assigned to metoprolol and pyronaridine-artesunate, with metoprolol given alone before the combination period. The arm description includes a 7 day washout after metoprolol, a 87 day follow-up period after the combination, and subsequent pyronaridine-artesunate redosing. The available description does not give the complete final regimen details.
The other arm received pyronaridine-artesunate for 3 days, followed by a 57 day follow-up period, then another 3-day course and a 40 day follow-up period. The registry labels the redosing schedules as 90-day and 60-day redosing, respectively. The detailed schedule and the named arm labels are not identical in the excerpted descriptions, so the labels should be interpreted as the registry's intended grouping rather than as evidence of an exact day-by-day schedule beyond what is stated.
Open-label means that masking was not used, according to the registry. Randomization can help balance participant characteristics across groups, but the record does not report the sequence-generation method, allocation concealment, or other implementation details. The parallel model means participants were assigned to a group rather than all receiving each study regimen in a crossover comparison; the record does not provide additional design details. The registry record does not report a protocol, sample-size justification, or planned interim analyses.
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
| Stage | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| STARTED | 26 | 30 |
| COMPLETED | 24 | 19 |
| NOT COMPLETED | 2 | 11 |
Reasons for not completing this period:
| Reason | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| Withdrawal by Subject | 1 | 3 |
| Lost to Follow-up | 1 | 0 |
| Adverse Event | 0 | 8 |
Period 2
| Stage | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| STARTED | 24 | 19 |
| COMPLETED | 18 | 13 |
| NOT COMPLETED | 6 | 6 |
Reasons for not completing this period:
| Reason | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| Withdrawal by Subject | 4 | 1 |
| Adverse Event | 2 | 5 |
Period 3
| Stage | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| STARTED | 18 | 0 |
| COMPLETED | 14 | 0 |
| NOT COMPLETED | 4 | 0 |
Reasons for not completing this period:
| Reason | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
| Adverse Event | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: 26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)
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 | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Re-dosing | Arm B: Pyronaridine-artesunate 60-day Re-dosing | Total |
|---|---|---|---|---|
| Participants analysed | 26 | 30 | 56 | |
| Age, Continuous | years | 45 (SD 7.1) | 42 (SD 9.4) | 43 (SD 8.4) |
| Sex: Female, Male: Female | Participants | 13 | 14 | 27 |
| Sex: Female, Male: Male | Participants | 13 | 16 | 29 |
| Race/Ethnicity, Customized: Caucasian | Participants | 24 | 30 | 54 |
| Race/Ethnicity, Customized: Black | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Oriental/Asian | Participants | 1 | 0 | 1 |
| Body weight | kg | 74.4 (SD 11.37) | 69.8 (SD 10.15) | 71.9 (SD 10.88) |
| Height | cm | 171 (SD 8.2) | 170 (SD 7.4) | 171 (SD 7.8) |
| BMI | kg/m^2 | 25.3 (SD 2.59) | 24.1 (SD 2.67) | 24.6 (SD 2.68) |
| CYP2D6 Phenotype: Poor metabolizer | Participants | 1 | 2 | 3 |
| CYP2D6 Phenotype: Intermediate metabolizer | Participants | 11 | 13 | 24 |
| CYP2D6 Phenotype: Extensive metabolizer | Participants | 13 | 14 | 27 |
| CYP2D6 Phenotype: Ultra-Rapid metabolizer | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as World Health Organization (WHO) Treatment Emergent Adverse Events, measured over 140 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the number of participants with WHO treatment-emergent adverse events during 140 days. Treatment-emergent adverse events are events recorded after treatment begins; the registry describes severity grades from mild through fatal. The outcome is expressed as participants, so its basic form is a count of people who experienced an event, rather than a count of every event or a time-to-event measure.
Safety outcomes are used to describe what adverse events occurred during and after exposure, including their severity and the number of participants affected. This is relevant to a redosing study because repeated exposure may be followed by adverse events that need to be recorded over the assessment period. The registry's stated objective is to assess the safety of redosing a 3-day pyronaridine-artesunate regimen.
The endpoint description includes multiple severity categories, while the primary outcome is framed as participants with treatment-emergent adverse events. The record does not clarify whether the primary count includes all grades, only selected grades, or participants counted once regardless of the number of events. Nor does it report a complete category-by-time-point result for the primary outcome. The registry record therefore does not support treating the posted serious-event counts as a complete summary of every aspect of the primary endpoint.
WHO grading provides a common severity framework, but an event count alone does not establish cause. Attribution procedures, event definitions beyond the grade descriptions, and the handling of recurring events are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures show that serious adverse events were reported for 0 of 26 participants in the arm labelled metoprolol drug interaction and pyronaridine-artesunate 90-day redosing, and for 2 of 30 participants in the pyronaridine-artesunate 60-day redosing arm. Deaths were reported for 0 participants in each arm. These are descriptive counts. The registry record does not provide a statistical comparison, confidence intervals, or a p-value for serious adverse events.
For other adverse events, the record reports 25 of 26 participants in the 90-day redosing arm and 29 of 30 in the 60-day redosing arm as affected. These counts indicate that other adverse events were recorded for participants in both groups. They do not show the number of events per participant, the events' duration, or whether each event was judged related to study treatment. The registry record does not report those details.
The serious-event terms listed are Exanthema (rash) and Discus hernia (intervertebral disc protrusion), each reported as 3.3%. The registry does not give the denominator or further detail for these term-specific figures in the record excerpt. They should not be treated as evidence that the listed terms account for all serious events, or as estimates that can be directly compared across arms without the supporting counts and definitions.
Because the study was randomized, group assignment was intended to support comparisons, but the posted results do not include an inferential analysis. Randomization does not by itself make a descriptive difference conclusive, particularly when the record does not report a prespecified comparison, uncertainty interval, or adjustment plan. The event counts also arise from separate study questions: one arm included metoprolol and a drug-interaction assessment, while the other was a redosing arm. The groups therefore should not automatically be read as a clean comparison of redosing intervals alone.
The primary outcome is described over 140 days, but the posted record does not include a complete primary-outcome result broken out by severity category and assessment time. It also does not report how missing safety observations were handled or which participants were included in each analysis. These gaps constrain interpretation of the endpoint as a whole. The counts characterize what the registry reports; they do not establish that an event was caused by treatment, nor do they establish a comparative safety effect.
9. Statistical Methods Explained
Statistical interpretation begins with identifying what is counted and the group to which the count belongs. The registry describes the primary outcome as participants with treatment-emergent adverse events, and the posted safety figures give numbers at risk and numbers affected. A participant count is different from an event count: a participant can experience more than one event, but a count of affected participants records whether each person experienced an event under the stated definition. The record does not clarify the handling of multiple events for the primary endpoint.
What does a participant count tell the reader?
A count communicates how many participants met an outcome definition. Its interpretation depends on the corresponding group size, the event definition, and the follow-up period. The serious-event figures are reported alongside groups at risk, which gives context for the counts. The reported other-event counts are also shown with their group sizes. No additional percentages or comparative measures are needed to state these registry entries, and the registry does not report an inferential comparison for them.
A proportion is often used to describe the share of a group with an event. A rate instead uses accumulated time at risk, and a time-to-event analysis considers when events occur as well as whether they occur. Those approaches answer different questions. The posted record does not report participant-level event times or person-time, so the safety counts should not be described as rates or time-to-event estimates.
How should uncertainty be understood?
A confidence interval is a range of values compatible with the observed data under a statistical model. Its width reflects how precisely an estimate is determined, while its interpretation depends on the method and assumptions used. No confidence intervals for the safety comparisons are reported in the registry record. The counts alone therefore do not show the precision of an estimated difference between groups.
A p-value, when reported, assesses how compatible data are with a specified null model under stated assumptions. It does not measure the probability that a treatment caused an event, and it does not quantify the importance of an outcome. The registry record lists no analyses, and no p-values are reported for the safety counts. No conclusion about statistical significance can be drawn from the counts alone.
What does randomization contribute?
Random assignment can reduce systematic differences between groups at the start of a study, on average, when implemented appropriately. It does not guarantee that groups are identical, especially in a study with limited enrollment. The registry identifies the study as randomized but does not report sequence generation, allocation concealment, or details of how assignment was carried out. Open-label status means masking was absent, which can affect the reporting or assessment of subjective outcomes. The record does not describe additional safeguards for adverse-event assessment.
The parallel-group structure means different participants were assigned to the study groups rather than each participant serving as their own comparison across regimens. Such a design can be suitable for comparing assigned groups, but interpretation still depends on prespecified outcomes, group definitions, follow-up, and analysis. Here, the arms represent a drug-interaction regimen with 90-day redosing and a pyronaridine-artesunate regimen with 60-day redosing. Since one arm also includes metoprolol exposure, a difference between groups would not necessarily isolate the effect of redosing interval.
Why can over-dispersion matter?
General statistical context: count data are sometimes analysed with models that assume a particular relationship between the average count and its variability. Over-dispersion occurs when the data vary more than that model expects. It can make standard errors too small if ignored, leading to confidence intervals that are too narrow and p-values that appear more compelling than warranted. This consideration applies to analyses of event counts, but the registry record does not report a count model or an over-dispersion assessment. The primary outcome is described in terms of participants affected, and the available counts do not establish that such a model was used.
How should the endpoint and analysis plan be read?
The WHO outcome describes adverse-event severity, but the record does not report a complete breakdown of primary events by grade and time point. The registry also does not report a prespecified estimand, analysis population, handling of intercurrent events, or method for incomplete follow-up. These details matter because the same participant-level count can have different interpretations depending on which events qualify, how attribution is handled, and whether all randomized participants are included.
The record identifies six outcome measures and no analyses. This means the posted record does not offer a documented inferential analysis to interpret alongside the descriptive safety counts. A planning calculation based on an observed effect would not replace a trial's own design justification or constitute observed power; the registry record does not report its sample-size justification. Any sample-size planning illustrations should be read as hypothetical planning information, not as evidence about the precision or success of this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists six outcome measures and no analyses. It does not report which outcomes were designated secondary, how multiple outcomes or event categories were prioritized, or whether any adjustment for multiple comparisons was planned. Multiplicity matters when several outcomes, time points, or subgroup comparisons are examined: the chance of at least one apparently notable finding can increase as the number of analyses grows. This is general statistical context, not a statement that such a procedure was used in this trial.
The primary outcome description includes WHO severity grades and a 140-day timeframe, while the record also reports serious and other adverse-event counts. A complete mapping between these categories, outcome measures, and analysis time points is not reported in the registry record. No single primary comparison is reported in the posted results; the primary outcome has several categories or time points and is not reduced to one comparison.
Missing-data methods and the number of participants with incomplete follow-up are not reported in the registry record. It is also not reported whether the analysis included all randomized participants, only participants who received treatment, or another population. Without these details, readers cannot determine how incomplete observations could affect the event counts.
The record does not state whether adverse events were actively solicited, how event onset and resolution were recorded, or how treatment relatedness was assessed. The lack of reported detail does not show that these procedures were absent; it means they are not reported in the registry record. No imputation method or sensitivity analysis is reported.
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 |
|---|---|---|---|
| Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | 0 | 26 | 0.0% |
| Arm B: Pyronaridine-artesunate 60-day Redosing | 2 | 30 | 6.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | 0 of 26 |
| Arm B: Pyronaridine-artesunate 60-day Redosing | 0 of 30 |
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 |
|---|---|
| Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | 25 of 26 |
| Arm B: Pyronaridine-artesunate 60-day Redosing | 29 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|---|
| Exanthema (rash) | Skin and subcutaneous tissue disorders | 0 of 26 | 1 of 30 |
| Discus hernia (intervertebral disc protrusion) | Musculoskeletal and connective tissue disorders | 0 of 26 | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing | Arm B: Pyronaridine-artesunate 60-day Redosing |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 20 of 26 | 18 of 30 |
| Headache | Nervous system disorders | 15 of 26 | 16 of 30 |
| Alanine aminotransferase increased | Investigations | 13 of 26 | 16 of 30 |
| Aspartate aminotransferase increased | Investigations | 8 of 26 | 17 of 30 |
| Nausea | Gastrointestinal disorders | 12 of 26 | 11 of 30 |
| Gamma-glutamyltransferase increased | Investigations | 5 of 26 | 14 of 30 |
| Dizziness | Nervous system disorders | 9 of 26 | 6 of 30 |
| Fatigue | General disorders | 10 of 26 | 5 of 30 |
| Vomiting | Gastrointestinal disorders | 5 of 26 | 9 of 30 |
| Abdominal pain | Gastrointestinal disorders | 6 of 26 | 6 of 30 |
Serious events with the highest arm-level rate: exanthema (rash) (3.3%), discus hernia (intervertebral disc protrusion) (3.3%).
The serious adverse-event figures are counts of affected participants, not a measure of all adverse events or of their duration. The 90-day redosing arm reports 0 serious events among 26 participants at risk, while the 60-day redosing arm reports 2 among 30. The record reports 0 deaths in each arm. These figures are descriptive and are not accompanied by a statistical comparison or confidence intervals.
The other-event counts are 25 of 26 in the 90-day redosing arm and 29 of 30 in the 60-day redosing arm. The registry does not provide the event-level descriptions needed to assess how many events each participant experienced, how severe the other events were, or whether they were judged related to treatment.
The serious-event terms listed are Exanthema (rash) and Discus hernia (intervertebral disc protrusion), each reported as 3.3%. The record does not provide supporting term-specific counts or enough context to interpret those percentages as comparative estimates. Event terminology and attribution are not explained in the registry record.
These figures describe recorded events during the study; they do not establish causation. Differences in observed counts should not be treated as proof of a safety difference, especially without reported uncertainty estimates and a prespecified comparison.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, open-label phase 1 study in healthy volunteers addressing both a metoprolol drug-interaction question and pyronaridine-artesunate redosing. Its primary outcome concerns WHO treatment-emergent adverse events over 140 days. The reported safety counts indicate that serious adverse events and deaths were uncommon in the posted group summaries, while other adverse events were recorded for participants in both groups. The counts are descriptive, and the registry does not report inferential comparisons or uncertainty intervals.
That description is not the same as a conclusion that either regimen is safe or unsafe. A safety interpretation depends on the event definitions, seriousness and timing of events, treatment attribution, completeness of follow-up, and uncertainty around group estimates. Several of those details are not reported in the registry record. The available count summaries also do not show the full distribution of event severity or all time-specific primary-outcome results.
The arm structure also limits simple comparisons. The 90-day redosing arm included metoprolol and the drug-interaction sequence, whereas the 60-day redosing arm is described as pyronaridine-artesunate redosing. A difference between these groups would not, without additional design and analysis information, isolate the effect of the redosing interval. The record does not report a single primary comparative analysis that resolves this issue.
The results do not address whether pyronaridine-artesunate treats malaria effectively. Participants were healthy volunteers, and the stated objectives concern drug interaction and redosing safety. No malaria-treatment outcome is reported in the posted results. The study's enrollment and phase also mean that the record should be read as a limited safety and interaction investigation, not as a broad estimate of outcomes in people with malaria.
Accordingly, the meaningful statistical reading is narrow: the registry records the stated participant counts and event terms, but does not provide enough analysis detail to quantify comparative uncertainty or draw a causal conclusion. Missing analysis methods and incomplete endpoint detail should be kept distinct from evidence that an event did or did not occur.
13. Why This Trial Matters Statistically
This trial raises a useful statistical issue: a study can have multiple related objectives, while its registered primary outcome may not map neatly to one comparison. The registry combines a metoprolol drug-interaction question with pyronaridine-artesunate redosing at different follow-up intervals. These objectives require careful attention to which participants, exposures, and outcomes are being compared.
Safety reporting also illustrates why the outcome unit matters. Counts of participants affected are not counts of every event, and neither is equivalent to an event rate or a time-to-event measure. The record reports serious and other affected-participant counts, but it does not give the detailed event timing, recurrence, attribution, or analysis needed to interpret them as rates or as a comparative treatment effect.
The study is randomized, yet the registry does not report an inferential analysis, a sample-size justification, or uncertainty intervals for the safety figures. Randomization is a design feature, not a substitute for transparent reporting of the planned estimand, analysis population, and statistical methods. The distinction is particularly relevant when arms include different treatment sequences and one includes an additional drug-interaction component.
Finally, the record's WHO severity framework provides a structured way to classify adverse events, but a severity scale does not by itself supply a complete analysis. Readers need to know how grades, time points, and participant-level counts were combined. This trial therefore highlights how registry results can provide useful descriptive safety information while leaving important questions about endpoint construction and comparative precision unresolved.
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 record does not report a detailed protocol, statistical analysis plan, sample-size justification, or interim-analysis plan. It also does not describe randomization sequence generation or allocation concealment. These omissions prevent assessment of how the study was planned and implemented beyond the design labels recorded.
The primary outcome is described as WHO treatment-emergent adverse events over 140 days, but the record does not provide a complete result by severity grade and time point. It is unclear whether the participant count includes every grade, how repeated events were handled, or how treatment attribution was assessed. The reported serious and other-event counts do not resolve those questions.
The study is open-label, and the record does not describe blinded event adjudication or other procedures intended to limit assessment bias. The posted results do not include confidence intervals, p-values, or a specified comparison. Six outcome measures are listed, but the record does not describe multiplicity handling or identify a complete analysis hierarchy.
Missing-data procedures and analysis populations are not reported. The available arm descriptions do not include the full regimen details for the 90-day redosing group, and the intervention groups differ in whether metoprolol is included. Consequently, a simple contrast between the arms would not isolate the effect of redosing interval alone.
The study enrolled healthy volunteers and was intended to evaluate interaction and redosing safety. The record does not establish how these results apply to people with malaria or to settings outside the study. These are limits on interpretation, not evidence that the unreported procedures or analyses did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate — NCT01523002.
- Registry record last updated 2023-12-14; status last verified 2023-12.
- Results first posted 2023-12-14.
- 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
This completed phase 1 trial was randomized, open-label, and parallel-group, with 56 healthy volunteers enrolled. Its objectives were to evaluate interaction between metoprolol and pyronaridine-artesunate and to assess safety after repeat pyronaridine-artesunate regimens at 60- or 90-day intervals. The primary outcome was WHO treatment-emergent adverse events over 140 days.
The posted safety figures report 0 serious events among 26 participants and 0 deaths in the 90-day redosing arm; the 60-day redosing arm reports 2 serious events among 30 participants and 0 deaths. Other adverse events were reported for 25 of 26 and 29 of 30 participants, respectively. Exanthema (rash) and Discus hernia (intervertebral disc protrusion) are each listed at 3.3% among serious-event terms.
Comparative analyses, confidence intervals, p-values, missing-data methods, and a sample-size justification are not reported in the registry record. The posted counts should therefore be read as descriptive safety information, not as a causal or inferential comparison.