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 An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys (NCT01011738), a registered phase not stated study. The primary outcome is Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01011738 |
| Phase | Phase not stated |
| Condition | Hepatitis B, Chronic |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1842 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled people with chronic hepatitis B who received Pegasys as part of standard care. The target population was defined using protocol inclusion and exclusion criteria, and the modified intention-to-treat population included participants whose HBeAg status could be classified. The registry record does not give the full eligibility criteria or the number included in the primary analysis.
Intervention
Participants received Pegasys, also called peginterferon alfa-2a 40KD. This was an observational, non-interventional study: the registry describes treatment received in standard care rather than a treatment assigned by the study.
Comparator
No randomized or like-for-like control group is described. The record identifies a cohort and distinguishes participants by HBeAg status, including positive, negative, and unknown status in the safety information. Those categories are descriptive groups, not randomized treatment comparisons.
Primary question
The primary outcome was the percentage of participants with hepatitis B surface antigen clearance by the end of the observation period, up to 276 weeks. Clearance meant that the measurement was negative or below the reported lower limit of detection. The study also assessed response predictors and several secondary outcomes. The primary outcome estimate itself is not reported in the registry record.
The central statistical question is therefore descriptive: among the observed participants receiving Pegasys in routine care, how often was surface antigen clearance recorded, and how did response patterns relate to participant characteristics such as HBeAg status? Because treatment assignment was not randomized and there is no comparable control group, the study cannot isolate a treatment effect by comparing treated participants with an untreated group. The registry description says participants were followed during treatment and for up to 3 years thereafter. It does not report the exact analysis population size, detailed predictor models, or numerical primary outcome results.
3. Trial Design
This was a multicenter, prospective, observational, non-interventional cohort study of people with chronic hepatitis B receiving Pegasys. The registry lists an enrollment of 1842 and identifies Hoffmann-La Roche as the sponsor. The study began on 2009-04-11, reached primary completion on 2014-11-18, and has a completed status. Participants were followed for the duration of treatment and for up to 3 years after treatment.
The study was designed to evaluate predictors of response in participants with HBeAg-positive and HBeAg-negative chronic hepatitis B. Efficacy and safety parameters were also to be evaluated. As treatment was received as standard care and the study was non-interventional, the record does not describe randomized allocation. It also does not report a control arm suitable for a like-for-like treatment comparison. Differences between HBeAg categories should consequently be interpreted as observed group differences, not as evidence that HBeAg status caused a difference in outcome.
The primary outcome was hepatitis B surface antigen clearance, assessed through the end of observation, with a stated timeframe of up to 276 weeks. The registry lists 17 outcome measures and six analyses. Secondary outcomes include viral DNA suppression, HBeAg seroconversion and loss among HBeAg-positive participants, combined seroconversion and viral DNA outcomes, surface antigen seroconversion, quantitative surface antigen, alanine transaminase normalization, and alanine transaminase ratios over time by HBeAg status.
Important design details are not reported in the registry record. These include the full inclusion and exclusion criteria, the planned sample-size justification, the timing and operational details of assessments, and the complete statistical analysis plan. The primary population description is incomplete, so the exact analyzed population and its size cannot be established from the registry description.
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.
Overall Study
| Stage | HBeAg Positive | HBeAg Negative | HBeAg Status Unknown |
|---|---|---|---|
| STARTED | 877 | 912 | 53 |
| COMPLETED | 553 | 618 | 36 |
| NOT COMPLETED | 324 | 294 | 17 |
Reasons for not completing this period:
| Reason | HBeAg Positive | HBeAg Negative | HBeAg Status Unknown |
|---|---|---|---|
| Death | 12 | 3 | 0 |
| Unknown reasons | 312 | 291 | 17 |
Analysis population for the primary outcome, as defined in the registry: mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).
| Characteristic | Unit | HBeAg Positive | HBeAg Negative | HBeAg Status Unknown | Total |
|---|---|---|---|---|---|
| Participants analysed | 863 | 890 | 48 | 1801 | |
| Age, Continuous | Years | 31.1 (SD 9.37) | 37.8 (SD 10.81) | 38.6 (SD 12.69) | 34.6 (SD 10.67) |
| Sex: Female, Male: Female | Participants | 257 | 231 | 11 | 499 |
| Sex: Female, Male: Male | Participants | 606 | 659 | 37 | 1302 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance, measured over Up to 276 Weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants who became hepatitis B surface antigen negative by the end of the observation period. The registry defines clearance as either a measurement reported as negative or a quantitative result below the reported lower limit of detection. The stated timeframe is up to 276 weeks, and the observation period is described as extending up to 3 years after treatment.
This endpoint expresses the observed proportion meeting a specified laboratory-based response definition. A percentage is useful for describing how frequently the endpoint was recorded in the analyzed population. The accompanying 95% confidence interval is intended to convey the statistical uncertainty around that estimate: it describes a range of values compatible with the observed data under the interval’s assumptions. It does not account for every source of uncertainty, such as selection into the cohort, measurement practices, or differences in participants’ clinical circumstances.
The registry describes two approaches to missing endpoint measurements. Analysis A included all participants in the analyzed population and counted participants missing a measurement needed for the endpoint as non-responders. Analysis B included only participants without missing measurements needed to calculate the endpoint, an as-observed approach. These approaches define different analysis populations and can yield different estimates when endpoint data are missing. Numerical estimates for either analysis are not reported in the registry record, so the magnitude and precision of the primary endpoint cannot be assessed from the record description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry description identifies the outcome and its rules for classifying clearance, but the primary outcome estimate is not reported in the registry record. There is therefore no reported percentage or confidence interval in these study details from which to describe the observed frequency of clearance or its precision. No conclusion about the size of the response can be drawn from the endpoint definition alone.
The outcome definition is specific: a participant counted as having clearance when the surface antigen result was negative or when a quantitative result fell below the reported lower limit of detection. This makes the classification depend on laboratory reporting and the detection limit used. The registry does not report those assay details or how measurement differences across participating centers were addressed. A reader should distinguish the endpoint’s definition from evidence about how often it occurred; the former is described, while the latter is not reported in the registry record.
The record names two analysis approaches. Analysis A treated a missing endpoint measurement as non-response, while Analysis B used participants with endpoint measurements available for calculation. These estimates would answer related but distinct descriptive questions: the first incorporates missing observations into the non-responder category, and the second describes observed measurements among participants with the required data. Neither approach, on its own, removes bias if missingness is related to response or participant characteristics. The number missing, reasons for missingness, and numerical estimates are not reported in the registry record.
The cohort was observational and non-interventional. Participants received Pegasys as standard care, rather than being randomly assigned by the study. The design can describe outcomes among those observed and can investigate associations between response and recorded characteristics. It cannot establish from a treated-only cohort whether an outcome was caused by treatment, nor does it support a direct treatment comparison without an appropriate comparison group. The record explicitly indicates that the listed groups are not a like-for-like control comparison.
HBeAg status is relevant to the study’s stated focus and to several secondary endpoints. The safety record separates participants into HBeAg-positive, HBeAg-negative, and unknown-status groups. Such categories can support descriptive comparisons, but differences between them may reflect baseline characteristics, clinical history, follow-up, or other factors. The registry description does not report adjusted effects or enough model detail to determine how potential confounding was handled.
The study lists multiple efficacy and safety outcomes, including 17 outcome measures and six analyses. The multiplicity approach, if any, is not reported in the registry record. Consequently, the registry description does not establish whether results across outcomes were treated as exploratory, whether any adjustment was used, or how the primary outcome was prioritized analytically. The absence of numerical outcome estimates, analysis details, and missing-data counts limits interpretation to the design and endpoint definitions rather than the observed efficacy findings.
9. Statistical Methods Explained
General: A cohort study follows people grouped by characteristics or exposures observed in practice and describes outcomes over time. In this study, treatment was received in standard care and the research was observational and non-interventional. This design can characterize the participants and outcomes included in follow-up, but it does not create randomized groups. Treatment comparisons are especially vulnerable to confounding when the people receiving different care, or falling into different clinical groups, also differ in ways related to outcomes.
The registry’s primary endpoint is a binary classification at the participant level: clearance was either achieved according to the stated laboratory rule or it was not. The outcome is then expressed as a percentage of participants. The registry describes the primary measure as a percentage and specifies a 95% confidence interval. General: A confidence interval communicates uncertainty in an estimate due to sampling variability under its statistical assumptions. A narrower interval generally indicates greater precision than a wider interval, but it does not address systematic problems such as selective enrollment, missing outcomes, measurement error, or confounding. The numerical interval and estimate are not reported in the registry record.
The endpoint classification combines two possible laboratory reports: a negative result, or a quantitative result below the reported lower limit of detection. General: A threshold-based definition converts a measurement into a category, which can make an outcome easier to summarize but may discard information about values above or below the threshold. When detection limits or laboratory procedures differ, comparability can be affected. The registry does not report assay-specific details, the detection limits used, or procedures for harmonizing measurements across centers.
The record describes Analysis A and Analysis B for the primary endpoint. Analysis A counted participants with missing endpoint measurements as non-responders within the analyzed population. This approach preserves those participants in the denominator but makes the result depend on the assumption that missing measurements should be classified as no response. If missingness is connected to outcome status, that assumption may distort the descriptive estimate. Analysis B used only participants without missing measurements needed for calculation, described as an as-observed analysis. This avoids assigning an endpoint value to missing measurements, but the resulting group may differ from the full analyzed population. General: Complete-case estimates can be biased when inclusion in the analysis is associated with outcome or participant characteristics. The registry does not report missingness counts, reasons, or sensitivity analyses.
The population description states that the modified intention-to-treat population included participants in the target population who could be classified by HBeAg status. It also refers to protocol inclusion and exclusion criteria and assessment-time availability, but the description is incomplete. The full population definition, analysis denominator, and numbers excluded from each analysis are not reported in the registry record. As a result, the specific scope of the endpoint estimate cannot be reconstructed from the available description.
The record lists 17 outcome measures and six analyses. General: When investigators examine multiple outcomes or conduct multiple analyses, the chance of finding an apparently notable result by chance can increase. A prespecified hierarchy, limited primary testing, or an adjustment procedure may address that issue, depending on the purpose of the analyses. The multiplicity strategy for this study is not reported in the registry record. The presence of several outcomes alone does not establish that an adjustment was or was not performed.
The registry also describes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated illustration is not the study’s own design justification. The actual numerical planning values are not reported in the registry entries, and the study itself is an observational cohort rather than a randomized two-arm comparison. Any such planning values should therefore be understood as hypothetical planning illustrations, not as observed power or as a description of the cohort’s actual design. A sample-size calculation describes assumptions about a future or hypothetical comparison; it does not measure the probability that the completed study found a true effect.
General: Over-dispersion is variation greater than expected under a simple statistical model. For binary outcomes, this can arise when participants have different underlying probabilities of an event or when observations are clustered within centers. If a model assumes less variation than the data contain, its uncertainty estimates may be too small. The registry description does not report whether over-dispersion was assessed, what regression models were used, or whether center-level clustering was handled.
The observational design also affects interpretation of predictor analyses. An association between a participant characteristic and the endpoint would describe a relationship in the analyzed cohort. It would not show that changing the characteristic would change the endpoint. The registry states that on-treatment predictors of response were a focus, but the predictor variables, model specification, adjustment set, handling of repeated measurements, and model diagnostics are not reported in the registry record. No adjusted estimates or numerical predictor results are available in the study details.
10. Multiplicity, Missing Data and Analysis Populations
The study lists 17 outcome measures and six analyses, including a primary endpoint and several secondary outcomes. The registry record does not report a multiplicity strategy, such as a prespecified testing hierarchy or an adjustment for examining multiple outcomes. It is therefore not possible to determine from the registry description how the analyses were prioritized or how the possibility of chance findings across several outcomes was addressed. The listed number of outcomes does not by itself indicate that all were tested as confirmatory hypotheses.
Missing endpoint data were handled in two stated ways. Analysis A included participants with missing measurements in the analyzed population and classified them as non-responders for the endpoint. Analysis B included only participants with the measurements needed to determine the endpoint and was described as as observed. These approaches make different assumptions and describe different analysis sets. The registry does not report the number of participants with missing measurements, the reasons for missingness, or whether additional sensitivity analyses were performed.
The modified intention-to-treat population was defined as participants in the target population who could be classified by HBeAg status. The target population was tied to protocol inclusion and exclusion criteria, but the population description is incomplete. The full criteria, the exact analyzed population size, and the number of participants included in each primary analysis are not reported in the registry record. Without these details, the relationship between enrollment and the endpoint denominators cannot be assessed.
The sample-size illustration is described as based on the observed effect and hypothetical two-arm assumptions. It should not be read as a justification for this observational cohort’s enrollment or as observed power. The registry record does not report the study’s own sample-size justification.
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 |
|---|---|---|---|
| HBeAg Positive | 47 | 863 | 5.4% |
| HBeAg Negative | 63 | 890 | 7.1% |
| HBeAg Status Unknown | 2 | 48 | 4.2% |
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 |
|---|---|
| HBeAg Positive | 522 of 863 |
| HBeAg Negative | 562 of 890 |
| HBeAg Status Unknown | 30 of 48 |
Most frequent serious adverse event terms
| Event term | Organ system | HBeAg Positive | HBeAg Negative | HBeAg Status Unknown |
|---|---|---|---|---|
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 863 | 8 of 890 | 0 of 48 |
| Alanine Aminotransferase Increased | Investigations | 4 of 863 | 2 of 890 | 0 of 48 |
| Neutropenia | Blood and lymphatic system disorders | 4 of 863 | 1 of 890 | 0 of 48 |
| Liver Disorder | Hepatobiliary disorders | 3 of 863 | 2 of 890 | 0 of 48 |
| Transaminases Increased | Investigations | 2 of 863 | 3 of 890 | 0 of 48 |
| Appendicitis | Infections and infestations | 1 of 863 | 3 of 890 | 0 of 48 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 863 | 3 of 890 | 0 of 48 |
| Hepatic Function Abnormal | Hepatobiliary disorders | 1 of 863 | 2 of 890 | 0 of 48 |
| Anaemia | Blood and lymphatic system disorders | 0 of 863 | 2 of 890 | 0 of 48 |
| Ascites | Gastrointestinal disorders | 1 of 863 | 1 of 890 | 0 of 48 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HBeAg Positive | HBeAg Negative | HBeAg Status Unknown |
|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 54 of 863 | 183 of 890 | 9 of 48 |
| Pyrexia | General disorders | 146 of 863 | 92 of 890 | 2 of 48 |
| Neutropenia | Blood and lymphatic system disorders | 72 of 863 | 153 of 890 | 5 of 48 |
| Headache | Nervous system disorders | 84 of 863 | 121 of 890 | 7 of 48 |
| Asthenia | General disorders | 63 of 863 | 124 of 890 | 7 of 48 |
| Leukopenia | Blood and lymphatic system disorders | 55 of 863 | 125 of 890 | 6 of 48 |
| Fatigue | General disorders | 89 of 863 | 93 of 890 | 3 of 48 |
| Alopecia | Skin and subcutaneous tissue disorders | 113 of 863 | 67 of 890 | 1 of 48 |
| Influenza Like Illness | General disorders | 69 of 863 | 92 of 890 | 4 of 48 |
| Myalgia | Musculoskeletal and connective tissue disorders | 81 of 863 | 74 of 890 | 2 of 48 |
Serious events with the highest arm-level rate: cholecystitis (2.1%), arthralgia (2.1%), hepatocellular carcinoma (0.9%), neutropenia (0.5%), alanine aminotransferase increased (0.5%).
The registry safety figures distinguish HBeAg-positive, HBeAg-negative, and HBeAg-status-unknown groups. For serious events, the record lists 863 participants at risk and 47 affected in the HBeAg-positive group; 890 at risk and 63 affected in the HBeAg-negative group; and 48 at risk and 2 affected in the unknown-status group. These are group-specific counts as recorded, not randomized comparisons. The registry description does not give a basis for interpreting differences between the groups as caused by treatment or HBeAg status.
The record also lists serious-event terms with percentages: Cholecystitis, 2.1%; Arthralgia, 2.1%; Hepatocellular Carcinoma, 0.9%; Neutropenia, 0.5%; Alanine Aminotransferase Increased, 0.5%; and Liver Disorder, 0.3%. The registry description does not specify the denominator or further detail for these term percentages. They should be read as the listed serious-event figures rather than as rates adjusted for follow-up time.
For the separate other-event category, the record gives 863 affected among 863 at risk in the HBeAg-positive group, 562 affected among 890 at risk in the HBeAg-negative group, and 30 affected among 48 at risk in the unknown-status group. Death counts are not reported in the registry record. Event definitions, severity grading details, and exposure-adjusted rates are not reported in the registry description.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective observational cohort was assembled to evaluate response predictors and other efficacy and safety outcomes among people with chronic hepatitis B receiving Pegasys in standard care. It also defines the primary endpoint as hepatitis B surface antigen clearance, with a specified laboratory-based classification rule, and describes two approaches to missing endpoint measurements. These details clarify what the study intended to measure and how the primary endpoint was to be summarized.
The record does not report the primary endpoint percentage or its confidence interval. It therefore does not establish the observed frequency of clearance or the precision of that estimate. The absence of that result also means the efficacy findings cannot be characterized from the information available in the registry description. An endpoint definition is not itself an outcome result.
The study’s non-interventional design is important. It can describe outcomes and associations among participants observed in routine care, but treatment was not randomly assigned by the study and no like-for-like control comparison is described. Associations between response and HBeAg status, or other characteristics, would not automatically identify causal effects. Differences may reflect participant characteristics, clinical decisions, follow-up, or measurement practices.
The reported safety counts and serious-event terms provide descriptive information by HBeAg category and for listed event terms. They do not establish comparative safety against an untreated or randomized control group. The record does not report deaths, detailed event exposure time, or the denominator behind the listed term percentages, limiting interpretation of those figures.
Accordingly, the registry description supports conclusions about study design, outcome definitions, analysis populations as described, and selected safety counts. It does not support a judgment about the magnitude or certainty of the primary response estimate, a causal claim about treatment, or a complete assessment of safety. Numerical efficacy results and several methodological details are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of how an observational cohort can be structured around a clinically defined response endpoint. The registry specifies a binary clearance definition, a follow-up period extending up to 276 weeks, and two ways of handling missing primary endpoint measurements. Those choices matter because an endpoint’s operational definition and missing-data rule directly shape the population and outcome being summarized.
The study also illustrates the distinction between describing outcomes in treated participants and estimating a treatment effect. Participants received Pegasys in standard care, and the record does not describe random assignment or a like-for-like control group. A cohort can provide evidence about observed outcomes and possible predictors, while causal interpretation requires careful attention to confounding and selection. The registry’s design description therefore sets clear boundaries on the claims that could be supported.
Its focus on HBeAg-positive and HBeAg-negative participants highlights the need to distinguish clinically defined subgroups from randomized arms. Subgroup results may be useful for describing patterns, but they can be difficult to compare without information about baseline differences, analysis methods, and uncertainty. The registry lists several secondary outcomes as well as the primary endpoint, making transparent reporting of analysis populations and multiplicity especially relevant.
The record is also a reminder that enrollment and study completion do not replace outcome reporting. Enrollment is listed as 1842, but the primary analysis denominator and numerical clearance estimate are not reported in the registry description. Without those results, readers can understand the design and planned measurement but cannot assess the observed response or its precision. Missingness counts, model details, and the multiplicity approach would also help readers evaluate how robustly the available data answer the stated questions.
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 primary outcome estimate and its 95% confidence interval are not reported in the registry record. This is the most direct limitation for interpreting the study’s main efficacy question: the endpoint definition is described, but the observed result and its precision cannot be assessed. Numerical results for the secondary efficacy outcomes are also not included in the study details.
The primary population description is incomplete. It refers to the target population defined through protocol eligibility criteria and to assessment-time availability, but the full definition is not stated. The exact analysis denominator, the numbers included in Analysis A and Analysis B, and the counts excluded from each analysis are not reported in the registry record.
The description does not give the frequency or reasons for missing primary endpoint measurements. Although two approaches to missing data are stated, there is no reported missingness summary or sensitivity analysis in the study details. The assumptions behind treating missing measurements as non-response, and the representativeness of participants with observed measurements, therefore cannot be evaluated.
As an observational, non-interventional cohort, the study does not provide randomized treatment allocation or a like-for-like control group. Confounding and selection may affect observed associations between participant characteristics and outcomes. The registry description does not report the predictor model specification, adjustment variables, assessment of center effects, or other model diagnostics.
The registry does not report assay details or how differences in measurement and detection limits across centers were handled. It also does not report the multiplicity strategy despite listing multiple outcomes and analyses. For safety, the denominator and further detail for serious-event term percentages, event exposure time, and death counts are not reported in the registry record. These omissions constrain interpretation of both efficacy and safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys — NCT01011738.
- Registry record last updated 2017-04-10; status last verified 2017-03.
- Results first posted 2016-04-08.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed, multicenter, prospective observational cohort study evaluated response predictors and efficacy and safety outcomes among people with chronic hepatitis B receiving Pegasys in standard care. Enrollment was 1842. The registry lists Hoffmann-La Roche as sponsor, a start date of 2009-04-11, and primary completion on 2014-11-18.
The primary endpoint was hepatitis B surface antigen clearance by the end of observation, defined as a negative result or a quantitative result below the reported lower limit of detection. The stated timeframe was up to 276 weeks. Analysis A counted missing endpoint measurements as non-response; Analysis B included participants with measurements available for endpoint calculation.
The record lists 17 outcome measures and six analyses. It includes safety counts by HBeAg status and several serious-event term percentages, but the primary outcome estimate and confidence interval are not reported in the registry record. Full population details, missing-data counts, the multiplicity strategy, and the complete statistical analysis plan are also not reported in the registry record.