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 Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis (NCT04818671), a na phase 3 study. The primary outcome is Number of AEs, SAEs and AESIs.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04818671 |
| Phase | Phase 3 |
| Condition | Generalized Myasthenia Gravis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 184 |
| Arms in the primary outcome | n/a |
| Lead sponsor | argenx |
| Results posted | Yes |
2. Clinical Question
The study asks whether repeated subcutaneous treatment with efgartigimod PH20 can be followed over the long term while characterizing safety and tolerability in participants with generalized myasthenia gravis. The primary outcome concerns adverse events, serious adverse events, and adverse events of special interest. The registry description also names clinical efficacy, immunoglobulin measures, pharmacokinetics, immunogenicity, quality of life, treatment satisfaction, administration preference, and the feasibility of self- or caregiver-supported injection as areas of interest.
Population
Participants with generalized myasthenia gravis. The registry lists enrollment of 184, while the safety analysis set includes participants exposed to study treatment.
Intervention
Efgartigimod PH20 SC, administered subcutaneously. The registry describes 1000 mg and treatment periods lasting 3 weeks, repeated as needed.
Comparator
There is no separate comparator group. This is a single-arm study, so its results do not provide a randomized or concurrent control comparison.
Primary question
What adverse events, serious adverse events, and adverse events of special interest were reported during follow-up of up to 3.5 years among participants exposed to treatment?
The registry identifies infections and infestations as adverse events of special interest because efgartigimod causes a transient reduction in total IgG levels. The described treatment schedule includes at least 28 days between treatment periods. These design features frame the safety question, but they do not establish how many treatment periods individual participants received or how exposure duration varied.
Although clinical efficacy and other measures are named in the study description, the posted results in this record focus on adverse-event summaries. The registry record does not report comparative efficacy estimates. Accordingly, the central statistical question that can be addressed from these results is descriptive: what safety events were recorded in the exposed group, and what limits apply when interpreting those counts without a control group?
3. Trial Design
This is a completed, multicenter phase 3 study with a single-group, open-label design. The registry lists enrollment of 184 participants with generalized myasthenia gravis. Participants received efgartigimod PH20 SC; allocation is listed as not applicable, and masking is listed as none. There is no control arm against which to compare the observed safety experience.
The treatment schedule is described as 3-week treatment periods, repeated as needed, with at least 28 days between treatment periods. The record describes efgartigimod PH20 SC 1000 mg. Follow-up for the primary safety outcome extends up to 3.5 years. The registry does not report how many treatment periods each participant received, the distribution of treatment exposure, or the amount of follow-up actually contributed by each participant.
The primary outcome is the number of adverse events, serious adverse events, and adverse events of special interest. The safety analysis set is defined as all participants exposed to efgartigimod PH20 SC in the study. The adverse-event summary lists 180 participants at risk for serious adverse events and 180 at risk for other adverse events. It lists 55 participants affected by serious adverse events, 167 affected by other adverse events, and 5 deaths. The record separately lists serious adverse-event terms with reported percentages.
The registry also names outcomes concerning MG-ADL, total IgG, AChR-Ab, serum concentrations, antibodies against efgartigimod and rHuPH20, and other participant-reported or administration-related questions in its study description. However, numerical results for these outcomes are not reported in the registry record. Nor are outcome-specific analysis populations, analysis methods, or detailed schedules for those measures reported.
The completed status indicates that the study is no longer ongoing in the registry. It does not supply a comparison group or resolve the limitations of the single-arm design. The start date is 2021-04-26, and the primary completion date is 2024-12-31. Those dates describe the registered study timeline; they do not, by themselves, establish the amount of observation available for each participant.
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: All participants were adults with gMG who participated in ARGX-113-2001 or ARGX-113-1705. No randomization or blinding was performed because this was an open-label study.
Overall Study
| Stage | Efgartigimod PH20 SC |
|---|---|
| STARTED | 180 |
| COMPLETED | 138 |
| NOT COMPLETED | 42 |
Reasons for not completing this period:
| Reason | Efgartigimod PH20 SC |
|---|---|
| Withdrawal by Subject | 16 |
| Adverse Event | 5 |
| Lack of Efficacy | 5 |
| Death | 4 |
| Physician Decision | 4 |
| Requires Prohibited Medication | 4 |
| Lost to Follow-up | 2 |
| Approved Drug Available for Indication | 1 |
| Sponsor Request | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study
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 | Efgartigimod PH20 SC |
|---|---|---|
| Participants analysed | 180 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 139 |
| Age, Categorical: >=65 years | Participants | 41 |
| Age, Continuous | years | 50.8 (SD 15.50) |
| Sex: Female, Male: Female | Participants | 119 |
| Sex: Female, Male: Male | Participants | 61 |
| Race/Ethnicity, Customized: Asian | Participants | 16 |
| Race/Ethnicity, Customized: Black or African American | Participants | 2 |
| Race/Ethnicity, Customized: White | Participants | 161 |
| Race/Ethnicity, Customized: Multiple | Participants | 1 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 8 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 172 |
6. Primary Endpoint
The registry lists the primary outcome as Number of AEs, SAEs and AESIs, measured over Up to 3.5 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events, serious adverse events, and adverse events of special interest during follow-up of up to 3.5 years. The registry defines adverse events in the Infections and infestations system organ class as events of special interest, explaining that efgartigimod causes a transient reduction in total IgG levels. This makes infection-related events a prespecified safety focus in the study description.
Counting safety events is useful in a long-term study because it characterizes the types and burden of events recorded during exposure. Seriousness and special-interest status identify clinically important categories for safety monitoring. These measures are descriptive: they can show what was observed in the exposed participants, but without a control group they cannot establish how much of the event experience was caused by treatment or how it compares with what would have occurred otherwise.
The endpoint title refers to numbers of events, whereas the posted group summary reports participants at risk and participants affected. Those participant counts should not be mistaken for total event counts. The registry record does not report the total number of events in the summary presented, nor does it provide event-level timing, duration, recurrence, or exposure-adjusted rates. Such information would help distinguish a participant experiencing an event from repeated events in the same participant and would support more detailed assessment of event burden.
For the safety population, the record lists 180 participants at risk and 55 affected by serious adverse events. It lists 180 at risk and 167 affected by other adverse events. These figures describe the recorded safety experience, not a treatment effect. The registry does not report confidence intervals or a formal comparison for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety summary describes adverse events among participants exposed to efgartigimod PH20 SC. The serious adverse-event summary lists 55 affected participants among 180 at risk. The other adverse-event summary lists 167 affected participants among 180 at risk. These are participant counts, not totals of all events; a participant could experience more than one event, and the registry summary does not report the total event count.
The registry lists 5 deaths. It does not report in this record whether the deaths were considered related to treatment, the causes of death, their timing, or how they were classified within the adverse-event summary. The number should therefore be read as a safety observation, not as evidence about treatment causation.
Among serious adverse-event terms, myasthenia gravis is reported at 6.1%, pneumonia at 3.9%, COVID-19 at 2.2%, myasthenia gravis crisis at 2.2%, respiratory failure at 2.2%, and angina unstable at 1.1%. The registry record does not specify the denominator or calculation details for these percentages in the listed term summary. They should be interpreted as reported percentages, not converted into participant counts or treated as comparative risks.
The study is single-arm and open-label. Without a concurrent control group, it cannot distinguish events associated with treatment from events arising from the underlying condition, background risks, or other circumstances. This limitation is particularly relevant for safety outcomes in a population with a serious chronic condition: the presence of an event during follow-up does not by itself show that treatment caused it. Conversely, a descriptive count cannot establish that no risk exists.
The safety analysis set consists of participants exposed to treatment, and the registry lists 180 at risk for each of the two broad adverse-event groupings. The enrollment figure is 184. The record does not explain the difference between enrolled participants and the exposed safety population, or provide participant-level reasons for non-exposure or exclusion. The two figures refer to distinct registry descriptions and should not be substituted for one another.
Follow-up is described as extending up to 3.5 years, but actual follow-up and treatment exposure may differ across participants; the distribution is not reported in the registry record. Without person-time denominators, exposure-adjusted rates, or event timing, the summaries cannot describe how event frequency varied over time or with repeated treatment periods. The treatment schedule allows periods to be repeated as needed, so exposure could vary, but the record does not report how it varied.
Several clinical, laboratory, pharmacokinetic, and immunogenicity outcomes are named in the study description. Their numerical results are not reported in the registry record addressed by these safety summaries. The safety findings therefore do not answer the broader efficacy or quality-of-life questions described for the study. They characterize selected adverse-event summaries in an exposed cohort, with limited information for estimating precision, attribution, or comparative risk.
9. Statistical Methods Explained
Safety outcomes in a single-arm study are primarily descriptive. The registry reports how many participants were at risk and how many were affected in broad adverse-event categories. Such counts help describe the observed experience, but they are not randomized comparisons. Since every participant in the study received the study intervention, there is no concurrent untreated or active-control group to provide a direct reference for event frequency.
What is the difference between events and participants affected?
An event count and a participant count answer different questions. An event count records each qualifying occurrence; a participant count indicates how many people experienced an event. A participant may experience repeated events, and different participants may experience events with different severity, duration, or timing. The primary outcome title refers to numbers of events, but the posted summary gives participants at risk and participants affected. The registry record does not provide the total number of events in that summary, so the affected-participant counts should not be read as event totals.
For the serious adverse-event category, 180 participants are listed as at risk and 55 as affected. For other adverse events, the corresponding figures are 180 and 167. These counts describe the safety population as summarized in the registry. They do not provide event-level detail, and they do not show whether participants experienced one event or repeated events. The separate count of 5 deaths is also a descriptive observation; details of cause, timing, and treatment relationship are not reported in the registry record.
Why does the absence of a control group matter?
In a randomized comparative trial, groups are assigned to different interventions under a common study framework. A comparison can then estimate differences between groups, subject to assumptions and limitations. This study has a single group, so there is no treatment contrast to estimate. The observed adverse events may reflect the disease, participant characteristics, other care, treatment, or a combination of factors. The study design cannot separate these possibilities by comparing event rates within the trial.
General statistical principle: a confidence interval describes the uncertainty around an estimated quantity under a specified statistical method. It does not correct for confounding, create a missing control group, or establish causation. No confidence intervals for the adverse-event counts are reported in the registry record. Likewise, no comparative hypothesis test or p-value for the primary safety outcome is reported. The absence of such estimates means the record gives counts and percentages, not a precision-based estimate of a treatment-related difference.
How should percentages for event terms be read?
The listed serious adverse-event terms are accompanied by percentages: myasthenia gravis, 6.1%; pneumonia, 3.9%; COVID-19, 2.2%; myasthenia gravis crisis, 2.2%; respiratory failure, 2.2%; and angina unstable, 1.1%. The record does not state the denominator or calculation method alongside these term percentages. They should therefore be retained as reported rather than converted into counts. The registry also does not specify whether the term percentages refer to participants or event occurrences, nor does it report uncertainty intervals for them.
General statistical principle: the denominator is essential to interpreting a percentage. A percentage based on participants has a different meaning from a percentage based on event occurrences or person-time. If participants have different observation periods, a simple proportion also does not convey the rate per unit of time at risk. Exposure-adjusted rates can sometimes account for unequal observation time, but the registry record does not report such rates for these summaries.
Why does follow-up duration matter?
The primary outcome timeframe is up to 3.5 years. The treatment schedule includes 3-week periods that may be repeated as needed, with at least 28 days between treatment periods. These descriptions establish the planned framework, but the actual follow-up and exposure distribution are not reported. A participant observed for a longer time has more opportunity to experience an event than a participant observed briefly. Without participant-level follow-up or person-time, the counts cannot be interpreted as a rate that accounts for differing observation.
General statistical principle: repeated treatment and repeated observation can produce clustered data, because several events or measurements may come from the same participant. Analyses of such data may need to account for within-participant dependence. The registry record does not report whether the primary safety outcome was analyzed with a model, whether event recurrence was considered, or how time at risk was defined. No particular analytical approach can be inferred from the endpoint description alone.
What can the other measures contribute?
The study description names MG-ADL, total IgG, AChR-Ab, serum concentrations, immunogenicity outcomes, quality of life, treatment satisfaction, administration preference, and feasibility of self- or caregiver-supported injection. These measures address distinct questions: symptoms and function, biological measurements, drug exposure, immune response, and participant experience. Numerical results for these outcomes are not reported in the registry record. It is therefore not possible to interpret their magnitude, variability, or relationship to the adverse-event summaries from this record.
General statistical principle: a mean or change score describes a different feature of data from an event count, and each outcome calls for an analysis suited to its scale and design. The registry record does not report a statistical analysis plan for these measures, their handling of repeated measurements, or the methods used to address missing observations. Statistical methods should not be inferred from the names of outcomes or from the fact that a study is phase 3.
Finally, no trial-specific sample-size justification, interim analysis plan, or multiplicity procedure is reported in the registry record. General explanations of confidence intervals, event rates, or repeated-measures methods describe statistical concepts only; they do not establish that those methods were used in this study. The available interpretation should remain tied to the descriptive results and design details that the record actually reports.
10. Multiplicity, Missing Data and Analysis Populations
The study description names a broad set of outcomes, including safety events, MG-ADL, IgG, AChR-Ab, serum concentrations, immunogenicity, quality of life, treatment satisfaction, administration preference, and feasibility of self- or caregiver-supported administration. Multiple outcomes can create a multiplicity issue when many statistical tests are conducted: even if each test uses a conventional threshold, the chance of at least one chance finding can increase across a collection of tests. General statistical principle: multiplicity procedures can control or characterize that risk, but the appropriate approach depends on the prespecified questions and analysis plan.
The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a detailed statistical analysis plan. It also reports no analyses for this outcome summary. Without those details, the named secondary measures should not be treated as a family of confirmatory tests, and no claim about multiplicity control can be made.
Missing-data handling is also not reported in the registry record. The record does not explain how missing measurements, incomplete follow-up, withdrawal, or intermittent participation were handled for the listed outcomes. It does not provide the amount or pattern of missing data. This matters because participants with different follow-up can contribute different amounts of safety information, while missing clinical measurements can affect estimates based on repeated assessments.
The primary safety population is defined as all participants exposed to efgartigimod PH20 SC. The adverse-event summary lists 180 participants at risk, while enrollment is listed as 184. The registry record does not explain the distinction between these figures or report participant-level disposition details. It also does not state whether participants with incomplete data were included in analyses of the secondary outcomes.
No assumptions about imputation, censoring, interim looks, or multiplicity should be inferred. These elements are not reported in the registry record. Consequently, interpretation is limited to the reported descriptive safety counts and term percentages, without a documented basis for assessing missing-data sensitivity or confirmatory testing across outcomes.
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 |
|---|---|---|---|
| Efgartigimod PH20 SC | 55 | 180 | 30.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Efgartigimod PH20 SC | 5 of 180 |
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 |
|---|---|
| Efgartigimod PH20 SC | 167 of 180 |
Most frequent serious adverse event terms
| Event term | Organ system | Efgartigimod PH20 SC |
|---|---|---|
| Myasthenia gravis | Nervous system disorders | 11 of 180 |
| Pneumonia | Infections and infestations | 7 of 180 |
| COVID-19 | Infections and infestations | 4 of 180 |
| Myasthenia gravis crisis | Nervous system disorders | 4 of 180 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 4 of 180 |
| Angina unstable | Cardiac disorders | 2 of 180 |
| Cardiac failure congestive | Cardiac disorders | 2 of 180 |
| Cellulitis | Infections and infestations | 2 of 180 |
| Sepsis | Infections and infestations | 2 of 180 |
| Rib fracture | Injury, poisoning and procedural complications | 2 of 180 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Efgartigimod PH20 SC |
|---|---|---|
| Injection site erythema | General disorders | 55 of 180 |
| COVID-19 | Infections and infestations | 52 of 180 |
| Headache | Nervous system disorders | 48 of 180 |
| Nasopharyngitis | Infections and infestations | 36 of 180 |
| Diarrhoea | Gastrointestinal disorders | 32 of 180 |
| Upper respiratory tract infection | Infections and infestations | 32 of 180 |
| Injection site bruising | General disorders | 24 of 180 |
| Injection site pain | General disorders | 22 of 180 |
| Back pain | Musculoskeletal and connective tissue disorders | 22 of 180 |
| Injection site pruritus | General disorders | 21 of 180 |
Serious events with the highest arm-level rate: myasthenia gravis (6.1%), pneumonia (3.9%), covid-19 (2.2%), myasthenia gravis crisis (2.2%), respiratory failure (2.2%).
The adverse-event summary lists 180 participants at risk for serious adverse events and 55 affected. For other adverse events, it lists 180 at risk and 167 affected. These are counts of participants in the registry summary, not counts of every event occurrence. Participants may experience more than one event, and the registry record does not provide the total number of events, their duration, or their timing.
The record lists 5 deaths. It does not report causes, timing, or whether the deaths were considered related to treatment. The number should not be interpreted as a causal estimate.
The serious adverse-event terms with reported percentages are myasthenia gravis, 6.1%; pneumonia, 3.9%; COVID-19, 2.2%; myasthenia gravis crisis, 2.2%; respiratory failure, 2.2%; and angina unstable, 1.1%. The denominator and calculation details for these percentages are not reported in the registry record. They are therefore best read as registry-listed percentages, not converted into participant counts or compared as if they were rates from separate study arms.
Because the study is single-arm, the safety summaries describe events observed during exposure but do not show how event frequency compares with a control group. They also do not establish whether any event was caused by treatment.
12. What the Result Does, and Does Not, Mean
The results describe safety observations in a group of participants exposed to efgartigimod PH20 SC. The record lists 55 participants affected by serious adverse events among 180 at risk, 167 affected by other adverse events among 180 at risk, and 5 deaths. It also lists selected serious adverse-event terms and their percentages. These findings characterize what the registry reports for this study; they are not estimates of a difference between treatments.
The design is single-arm and open-label. Without a concurrent comparator, the results cannot establish whether the recorded events occurred more or less often because of treatment. The registry record does not report treatment attribution for the listed events or deaths. A temporal association between exposure and an event is not sufficient to determine causation, and a descriptive summary cannot separate treatment effects from disease-related or other risks.
The study description includes clinical efficacy and other outcomes, but their numerical results are not reported in the registry record. The safety information therefore cannot answer whether symptoms or function changed, whether biological measurements changed, or whether participant experience differed. It also cannot establish comparative effectiveness or benefit.
The timeframe extends up to 3.5 years, but actual follow-up and treatment exposure for individual participants are not reported. Counts alone do not account for differences in observation time. The registry also does not give total event counts, event timing, recurrence, or exposure-adjusted rates. These omissions limit assessment of event burden and its development over time.
In short, the record offers a descriptive account of selected safety outcomes in an exposed cohort. It does not provide a causal treatment estimate, a controlled risk comparison, or numerical findings for the other outcomes named in the study description. The distinction is important: observed safety data can inform a description of the cohort, while conclusions about comparative effects require evidence that this single-arm record does not contain.
13. Why This Trial Matters Statistically
Long-term safety assessment is statistically distinct from evaluating a short-term outcome. The study follows an open-label, single-arm structure, with treatment periods repeated as needed and follow-up extending up to 3.5 years. This creates a setting in which exposure and observation may vary across participants. Understanding how those differences are handled is important when interpreting event counts, yet exposure duration, actual follow-up, and person-time are not reported in the registry record.
The registry identifies infections and infestations as adverse events of special interest because efgartigimod causes a transient reduction in total IgG levels. That classification makes the safety question specific: the study is not only counting broad adverse events but also identifying an event category given particular monitoring attention in the study description. The record, however, does not provide detailed event timing or analyses connecting IgG measurements with infections.
The study also names clinical, laboratory, pharmacokinetic, immunogenicity, and participant-experience outcomes. This breadth can be useful for understanding different aspects of treatment, but it also makes transparent reporting of outcome definitions, analysis populations, missing-data methods, and multiplicity procedures important. These statistical details are not reported in the registry record.
For biostatistical interpretation, the key point is the distinction between a safety description and a comparative inference. Counts among exposed participants can document events reported during follow-up. A single-arm design cannot estimate a randomized between-group contrast, and the posted results do not give confidence intervals or exposure-adjusted rates. The record therefore illustrates why study design and denominator definitions matter alongside the observed counts.
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 single-arm, open-label design is the central limitation for interpreting safety. There is no concurrent control group, so the study cannot estimate a comparative event rate or separate treatment-related events from events associated with the underlying condition or other factors. The registry record does not report causal attribution for the listed serious adverse events or deaths.
The safety summary reports participants at risk and participants affected, but not total event counts. It does not describe event recurrence, severity detail beyond serious-event classification, duration, timing, or exposure-adjusted rates. The serious adverse-event term percentages are listed without denominator or calculation details in the record. These gaps limit interpretation of event burden and the meaning of the term-specific percentages.
Although follow-up is described as up to 3.5 years, the actual duration of observation for participants is not reported. The treatment schedule allows repeated 3-week periods as needed, separated by at least 28 days, but the number of periods received and cumulative exposure are not reported. Unequal exposure or follow-up could affect the opportunity to observe events; the available summary does not account for that with person-time measures.
Enrollment is listed as 184, while the safety summary lists 180 at risk. The record does not explain the difference or provide detailed participant disposition. It also does not report missing-data handling, outcome-specific analysis populations, statistical methods, confidence intervals, a sample-size justification, or a multiplicity plan. Numerical results for the named clinical, laboratory, pharmacokinetic, immunogenicity, and participant-experience outcomes are not reported in the registry record. These limitations constrain both statistical precision and the scope of conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis — NCT04818671.
- Registry record last updated 2026-01-22; status last verified 2026-01.
- Results first posted 2026-01-22.
- 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
NCT04818671 is a completed, multicenter, phase 3, single-arm, open-label study of efgartigimod PH20 SC in participants with generalized myasthenia gravis. The registry lists enrollment of 184. Treatment is described as 1000 mg in 3-week periods, repeated as needed with at least 28 days between periods. The primary safety timeframe is up to 3.5 years.
The primary outcome concerns adverse events, serious adverse events, and adverse events of special interest. The safety summary lists 180 participants at risk for serious adverse events, with 55 affected; it lists 180 at risk for other adverse events, with 167 affected, and 5 deaths. Selected serious adverse-event terms are reported with percentages.
The design has no comparator group. Numerical results for the other outcomes named in the study description, comparative estimates, confidence intervals, and detailed analysis methods are not reported in the registry record. The findings should be read as descriptive safety information for an exposed cohort.