This page separates information reported in the ClinicalTrials.gov record from statistical interpretation. The registry reports results for the registered endpoints, but the ClinicalTrials.gov record contains no formal entries in its statistical-analyses field.
1. Trial at a Glance
BORA was a randomized, double-masked, parallel-group phase 3 study in asthma. The study enrolled 2133 participants and evaluated benralizumab, with registered primary endpoints focused on changes from baseline in hematologic and chemistry laboratory parameters at Week 56 and, for adolescent participants from SIROCCO/CALIMA, Week 108.
| Feature | BORA |
|---|---|
| Trial name | BORA |
| NCT identifier | NCT02258542 |
| Therapeutic area | Pulmonology |
| Condition | Asthma |
| Phase | Phase 3 |
| Status | COMPLETED |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Primary purpose | OTHER |
| Enrollment | 2133 |
| Arms | 2 |
| Lead sponsor | AstraZeneca |
| Sponsor type | INDUSTRY |
| Results posted | Yes |
| Outcome measures posted | 42 |
2. Clinical Question
The ClinicalTrials.gov record describes BORA as a safety extension study evaluating the safety and tolerability of benralizumab in asthmatic adults and adolescents receiving inhaled corticosteroid plus LABA. The statistical questions represented by the registered primary endpoints are narrower: whether specified laboratory parameters changed from their study baseline values at prespecified follow-up times.
Population
Asthmatic adults and adolescents on inhaled corticosteroid plus LABA who entered this safety extension study after completing treatment in predecessor studies.
Intervention
Benralizumab, described in the registry as a biological intervention. The ClinicalTrials.gov record identifies both study arms as benralizumab.
Comparator
The ClinicalTrials.gov record identifies both arms as benralizumab and does not provide a distinct placebo or untreated comparator.
Primary question
How do prespecified hematologic and chemistry laboratory parameters change from baseline at Week 56 and, for specified adolescent participants, Week 108?
3. Trial Design
Benralizumab
- Benralizumab
- Biological intervention
Benralizumab
- Benralizumab
- Biological intervention
The ClinicalTrials.gov record does not identify different treatment regimens between the two arms. Therefore, this page does not assign a conventional "treatment versus placebo" interpretation to the randomized groups.
4. Trial Timeline
Study start
BORA began on November 19, 2014.
Primary completion
The registry lists October 18, 2017 as the primary completion date.
COMPLETED
The ClinicalTrials.gov record identifies the study as completed and indicates that results have been posted.
5. Primary Endpoints
BORA has 16 registered primary endpoints. They form a structured laboratory-safety assessment covering five hematologic or chemistry parameters, each evaluated at Week 56 in the full analysis set excluding MELTEMI patients and again at Week 108 among adolescents from SIROCCO/CALIMA.
| Endpoint | Time frame | Analysis population | Definition |
|---|---|---|---|
| Change From Baseline in Basophils | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Basophils. |
| Change From Baseline in Basophils | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Basophils. |
| Change From Baseline in Leukocytes | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Leukocytes. |
| Change From Baseline in Leukocytes | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Leukocytes. |
| Change From Baseline in Lymphocytes | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Lymphocytes. |
| Change From Baseline in Lymphocytes | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Lymphocytes. |
| Change From Baseline in Neutrophils | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Neutrophils. |
| Change From Baseline in Neutrophils | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Neutrophils. |
| Change From Baseline in Eosinophils | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Eosinophils. |
| Change From Baseline in Eosinophils | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Eosinophils. |
| Change From Baseline in ALT | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests ALT. |
| Change From Baseline in ALT | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of ALT. |
| Change From Baseline in AST | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests AST. |
| Change From Baseline in AST | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of AST. |
| Change From Baseline in Bilirubin | Week 56 | Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry test Bilirubin. |
| Change From Baseline in Bilirubin | Week 108 | Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Bilirubin. |
6. What These Endpoints Measure
All 16 registered primary endpoints are change-from-baseline laboratory endpoints. This is fundamentally different from a time-to-event endpoint such as survival. The basic quantity is the difference between a participant's follow-up laboratory value and the value designated as baseline for the study.
A positive change indicates that the follow-up measurement is numerically higher than baseline, while a negative change indicates that it is numerically lower. The clinical meaning of the direction depends on the particular laboratory parameter and its measurement scale.
The registry specifically defines the endpoints as changes from baseline rather than as categorical safety events. Consequently, a numerical change should not automatically be interpreted as an adverse event or as evidence of clinical harm or benefit without additional clinical context.
7. Results
The ClinicalTrials.gov record indicates that results were posted and that results were available for each of the 16 registered primary endpoints. However, the ClinicalTrials.gov recordset contains no formal statistical analyses. It therefore does not provide formal treatment-comparison estimates, confidence intervals, or p-values for these endpoints.
| Result information | What the ClinicalTrials.gov record reports |
|---|---|
| Results posted | Yes |
| Outcome measures posted | 42 |
| Primary endpoints with results posted | 16 |
| Formal statistical analyses reported | None |
| Between-arm estimates reported | None |
| Confidence intervals in the posted results | None |
| P-values in the posted results | None |
What can be concluded from the registry-reported endpoint data?
The registry confirms that the prespecified laboratory endpoints were measured and that results were posted for them. It does not, in the ClinicalTrials.gov record, provide a formal randomized comparison that can be summarized as an estimated difference between the two benralizumab arms.
For that reason, this page deliberately does not
8. Statistical Methodology
Change-from-baseline analysis
For a continuous laboratory endpoint measured at a prespecified follow-up time, a conventional analysis begins with the individual change from baseline. The analysis then summarizes the distribution of those changes within the relevant analysis population.
For a randomized comparison, a common approach is to compare mean change between groups, often using an analysis of covariance (ANCOVA) with the follow-up measurement as the dependent variable and baseline measurement as a covariate. Another possible approach, particularly when repeated measurements over multiple visits are analyzed jointly, is a longitudinal mixed-effects model. Neither method is identified as the formal analysis in the posted results, so neither should be presented as the analysis actually used in BORA.
A treatment-group contrast of this form would quantify how much the average laboratory change differs between randomized arms. Its interpretation depends on the endpoint, the analysis population, the variance model, and the way missing observations are handled.
Baseline adjustment
Laboratory measurements commonly have meaningful between-participant variability before follow-up. Adjusting for baseline can improve precision and account for differences in starting values. In an ANCOVA framework, the baseline value is included as a covariate rather than simply subtracting two group means.
Full Analysis Set
The registered endpoint wording explicitly identifies a Full Analysis Set for the Week 56 endpoints, with MELTEMI patients excluded. The adolescent Week 108 endpoints use a more specific analysis population: adolescents from SIROCCO/CALIMA.
Repeated measurements
The primary endpoint time frames reported here are Week 56 and Week 108. If multiple laboratory measurements were collected before those time points, a longitudinal model could use more of the available information than a single-visit comparison. However, the ClinicalTrials.gov record does not specify the complete visit schedule or the model used, so this remains a methodological explanation rather than a description of the actual BORA analysis.
Laboratory endpoints and distributions
Continuous laboratory measurements can have skewed distributions or values near assay limits. Depending on the laboratory parameter and observed data, investigators may examine means, medians, transformations, or robust summaries. The ClinicalTrials.gov record does not provide the numerical distributions needed to determine which approach was most appropriate for any particular parameter.
9. Statistical Methods Explained
Why is change from baseline useful?
Change from baseline accounts for each participant's starting laboratory value. Rather than comparing only the Week 56 or Week 108 values, the analysis asks how much each participant's value moved relative to that participant's own baseline.
Why might ANCOVA be used for these endpoints?
ANCOVA can compare follow-up values between randomized groups while adjusting for baseline laboratory values. This can improve statistical precision when baseline values explain some of the variation in follow-up measurements. The registry-reported BORA data do not identify ANCOVA as the actual prespecified method, so it should be regarded here as a standard methodological option rather than a reported BORA result.
Why might a mixed model be useful?
If laboratory measurements are collected repeatedly over time, a mixed-effects model can account for the correlation among measurements from the same participant and estimate treatment-group differences across visits. Again, the ClinicalTrials.gov record does not identify such a model as the formal BORA analysis.
What does the Full Analysis Set tell us?
The endpoint names specify the population in which each primary endpoint is evaluated. The Week 56 endpoints use the Full Analysis Set excluding MELTEMI patients, whereas the Week 108 endpoints use adolescents only from SIROCCO/CALIMA. These population definitions matter because an estimated change is meaningful only in relation to the participants included in its calculation.
Why is Week 56 different from Week 108?
The time frames define different statistical estimands. A Week 56 change describes the difference from baseline at Week 56, whereas a Week 108 change describes the difference from baseline at Week 108 in the specified adolescent population. These should not be treated as interchangeable measurements or combined into a single estimate.
Does a change from baseline automatically indicate a safety problem?
No. A numerical laboratory change is a measurement, not by itself a clinical diagnosis. Interpretation depends on the laboratory parameter, magnitude and distribution of change, reference ranges, clinical context, and whether the change is associated with other safety findings. The registry-reported primary endpoints are defined as laboratory changes and do not themselves establish clinical significance.
10. Safety Results
The ClinicalTrials.gov record provides serious adverse-event counts for the predecessor-study groups represented in BORA's safety information. These data are reported as affected participants divided by participants at risk.
| Source group / benralizumab regimen | Serious adverse events | Affected / at risk |
|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 | Serious adverse events | 102/783 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 | Serious adverse events | 94/793 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Serious adverse events | 10/49 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Serious adverse events | 9/49 |
The four reported fractions also have different denominators. Directly comparing the affected counts alone would therefore be misleading. Even comparing the proportions requires attention to the underlying predecessor study, dosing group, analysis population, and risk period.
11. Selection Bias and the Meaning of Baseline
The registry caveats identify an important limitation: patients in BORA had to complete treatment in predecessor studies before entering this study. The registry therefore notes that selection bias may exist.
This matters statistically because the BORA population is not simply a newly enrolled sample drawn from the full population of patients with asthma. Participants had already passed through eligibility and treatment requirements in predecessor studies. The observed laboratory changes and safety findings therefore describe this selected extension-study population.
Extension-study selection
Entry required completion of treatment in predecessor studies, creating the possibility that participants differ systematically from patients who did not enter the extension study.
Baseline definition
The registry states that baseline is defined for this study's entry value, not that every baseline measurement necessarily occurred before active treatment.
Prior exposure
Some participants had been treated previously, so a BORA baseline laboratory value cannot automatically be interpreted as a treatment-naive baseline.
Interpretation
Changes from the BORA baseline describe change during this study period relative to its defined entry value, not necessarily change from the first-ever exposure to benralizumab.
12. Randomization and What It Can — and Cannot — Establish
BORA is described as randomized. Randomization is a mechanism for assigning participants to study groups in a way intended to balance measured and unmeasured characteristics probabilistically across sufficiently large groups.
That design feature is important, but its interpretation depends on the contrast being estimated. The registry-reported arm descriptions identify benralizumab in both arms. Consequently, the ClinicalTrials.gov record does not establish a conventional causal contrast such as benralizumab versus placebo.
When both arms are identified with the same intervention in the ClinicalTrials.gov record, the appropriate statistical interpretation requires the actual arm-level regimen definitions before a treatment-versus-control conclusion can be made.
This distinction is especially important for a registry-based statistical analysis. It is preferable to preserve the registry-reported arm definitions than to infer an unstated comparator from the fact that the study is randomized.
13. Multiplicity and Sixteen Primary Endpoints
The trial has 16 registered primary endpoints. They represent repeated assessment of five laboratory parameters across two time frames and populations. Multiple primary endpoints create a statistical issue that is separate from the calculation of any individual change from baseline.
If formal hypothesis tests are performed for many endpoints, the probability of observing at least one apparently positive result can increase unless the testing strategy accounts for multiplicity. Possible approaches include hierarchical testing, Bonferroni-type procedures, alpha allocation, or other prespecified multiplicity-control methods.
The ClinicalTrials.gov record does not state which multiplicity strategy, if any, was used for these 16 endpoints. Therefore, no claim about familywise type I error control can be made from the ClinicalTrials.gov record.
| Statistical issue | BORA information reported | Interpretive implication |
|---|---|---|
| Number of primary endpoints | 16 | Multiple endpoints require attention to error control if formal hypothesis testing is performed. |
| Endpoint type | Change from baseline | Continuous laboratory analysis is appropriate in principle. |
| Time frames | Week 56 and Week 108 | Results represent different follow-up estimands. |
| Analysis populations | Full Analysis Set excluding MELTEMI; adolescents from SIROCCO/CALIMA | Population definitions differ across endpoint groups. |
| Multiplicity method | Not reported | No specific multiplicity procedure should be attributed to the trial from the registry record. |
14. Crossover, Factorial Design, Interim Analysis, and Bayesian Methods
The ClinicalTrials.gov record does not report a factorial design, crossover analysis, Bayesian methodology, or an interim-analysis strategy. These concepts therefore should not be presented as features of BORA.
Factorial design
Not identified in the ClinicalTrials.gov record. The registered design model is parallel.
Crossover
Not identified in the ClinicalTrials.gov record.
Interim analysis
No interim-analysis strategy is provided in the ClinicalTrials.gov record.
Bayesian methods
No Bayesian analysis is identified in the ClinicalTrials.gov record.
15. Missing Data and Imputation
Change-from-baseline analyses require both a baseline value and a follow-up value for the relevant calculation, unless a model-based method uses partial information. Missing laboratory observations can therefore affect both the analysis population and the estimated treatment-group contrast.
Common approaches include complete-case analysis, last-observation methods, multiple imputation, mixed-effects models, or other model-based approaches. The appropriate choice depends on why observations are missing and on the prespecified statistical analysis plan.
16. Clinical Biostats Interpretation of the Reported Results
The ClinicalTrials.gov record establishes that BORA was a randomized, double-masked, parallel phase 3 study with 2133 enrolled participants and that results were posted for its 16 registered primary laboratory endpoints.
The primary endpoints are changes from baseline in basophils, leukocytes, lymphocytes, neutrophils, eosinophils, ALT, AST, and bilirubin at specified follow-up times and in specified analysis populations. They are laboratory measurements rather than time-to-event outcomes.
The ClinicalTrials.gov record does not provide numerical between-arm estimates, confidence intervals, or p-values. It is therefore not appropriate to describe a statistically significant difference, a magnitude of treatment effect, or a confidence interval for any primary endpoint from the registry record.
Both registry-reported intervention descriptions identify benralizumab. Without a distinct comparator intervention in the ClinicalTrials.gov record, a conventional "benralizumab versus control" interpretation would go beyond the ClinicalTrials.gov record.
The registry explicitly notes that some participants had been treated previously and that baseline refers to the study's entry value. Consequently, a change from BORA baseline should not automatically be interpreted as a change from the participant's first exposure to active treatment.
17. Safety Interpretation
The serious-adverse-event data posted on ClinicalTrials.gov for the named predecessor-study groups are best understood as counts of affected participants among those at risk. A proportion is inherently dependent on its denominator, so the four reported groups should not be compared by raw event counts alone.
| Group | Affected | At risk | Statistical reading |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 | 102 | 783 | Serious adverse events occurred in 102 of 783 participants in the registry-reported group description. |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 | 94 | 793 | Serious adverse events occurred in 94 of 793 participants in the registry-reported group description. |
| ZONDA - Benralizumab 30 mg q.4 Weeks | 10 | 49 | Serious adverse events occurred in 10 of 49 participants in the registry-reported group description. |
| ZONDA - Benralizumab 30 mg q.8 Weeks | 9 | 49 | Serious adverse events occurred in 9 of 49 participants in the registry-reported group description. |
These figures should not be transformed into a comparative safety conclusion without knowing whether the groups are directly comparable, the relevant observation period, and the precise safety-analysis definitions. In particular, the named SIROCCO/CALIMA and ZONDA groups are not interchangeable with the two BORA randomized arms.
18. Endpoint-by-Endpoint Statistical Framework
| Laboratory parameter | Week 56 population | Week 108 population | Typical statistical question |
|---|---|---|---|
| Basophils | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| Leukocytes | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| Lymphocytes | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| Neutrophils | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| Eosinophils | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| ALT | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| AST | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
| Bilirubin | Full Analysis Set, excluding MELTEMI patients | Adolescents only (SIROCCO/CALIMA) | How does the parameter change from its BORA baseline? |
The repeated structure is statistically useful: each laboratory parameter has a Week 56 endpoint and a Week 108 endpoint, but the population definitions differ. This means the apparent longitudinal structure should not be mistaken for a single analysis of one unchanged population across both time points.
19. Important Limitations and Interpretation Issues
- Selection bias: the registry states that patients had to complete treatment in predecessor studies, so selection bias may exist.
- Baseline definition: baseline is defined for BORA study entry and not necessarily before active treatment because some participants were treated previously.
- Comparator ambiguity: both registry-reported arms are identified as benralizumab, so the dataset does not establish a conventional active-versus-control treatment contrast.
- Missing formal analyses: no formal statistical analyses were posted, preventing reporting of formal effect estimates, confidence intervals, and p-values.
- Multiple primary endpoints: 16 primary endpoints create a multiplicity issue if formal hypothesis tests are interpreted collectively, but the ClinicalTrials.gov record does not identify the multiplicity-control strategy.
- Different populations: Week 56 and Week 108 endpoints use different specified populations, so their results should not automatically be combined.
- Laboratory interpretation: numerical changes from baseline do not by themselves establish clinical significance or an adverse event.
- Safety denominators: the registry-reported serious-adverse-event groups have different denominators and arise from named predecessor-study groups.
- Prior treatment exposure: previous treatment means BORA baseline should not necessarily be interpreted as treatment-naive baseline.
- Missing-data methodology: the ClinicalTrials.gov record does not identify the imputation or modeling strategy for missing laboratory observations.
20. Why This Trial Matters Statistically
BORA is useful as a statistical teaching case because it illustrates a different problem from the familiar randomized trial with a single clinical efficacy endpoint. Its registered primary endpoints are repeated continuous laboratory assessments, while the study population is an extension cohort whose entry depends on predecessor-study treatment completion.
| Concept | How it appears in BORA |
|---|---|
| Randomization | The registry identifies allocation as randomized. |
| Parallel design | The design model is parallel with 2 arms. |
| Double masking | The registry identifies the study as double masked. |
| Change from baseline | All 16 registered primary endpoints use change from baseline. |
| Continuous outcomes | Basophils, leukocytes, lymphocytes, neutrophils, eosinophils, ALT, AST, and bilirubin are laboratory measurements. |
| Analysis populations | Week 56 uses the Full Analysis Set excluding MELTEMI patients; Week 108 uses adolescents from SIROCCO/CALIMA. |
| Multiplicity | There are 16 registered primary endpoints. |
| Extension-study selection | Participants had to complete treatment in predecessor studies. |
| Baseline interpretation | BORA baseline is the study entry value, and some participants had prior treatment. |
| Safety denominators | Serious AEs are reported as affected/at-risk counts for named predecessor-study groups. |
21. A Statistical Reading of the Study Architecture
The architecture of BORA suggests three separate statistical questions that should not be conflated.
Question 1: What changed?
For each laboratory parameter, the registered endpoint asks for change from baseline at a defined follow-up time.
Question 2: In whom was it measured?
The endpoint populations differ: Week 56 excludes MELTEMI patients from the Full Analysis Set, while Week 108 is restricted to adolescents from SIROCCO/CALIMA.
Question 3: How should groups be compared?
The ClinicalTrials.gov record establishes randomization but list benralizumab for both arms. The actual intervention contrast therefore requires the underlying registry arm details before a conventional treatment effect can be interpreted.
Question 4: How much uncertainty is present?
A formal answer would normally require an estimated contrast and its confidence interval. Those statistical-analysis values are not reported here.
This separation is important. A change-from-baseline estimate, a between-group treatment contrast, and a clinical interpretation are three different layers of analysis. A high-quality trial-results page should keep them distinct.
22. Planned Statistical Interpretation of the Laboratory Endpoints
Because the ClinicalTrials.gov record contains no formal statistical-analysis entries, the appropriate educational framework is to describe how endpoints of this type would ordinarily be analyzed rather than to reconstruct unreported results.
| Step | Typical analysis task | Purpose |
|---|---|---|
| 1 | Define baseline and analysis population | Ensure that the change is calculated consistently within the registered population. |
| 2 | Calculate or model change from baseline | Quantify movement in the laboratory parameter over the prespecified follow-up period. |
| 3 | Compare randomized groups when a defined contrast exists | Estimate a between-group difference in change. |
| 4 | Construct a confidence interval | Describe statistical precision around the estimated contrast. |
| 5 | Apply the prespecified multiplicity strategy | Control the interpretation of multiple primary endpoint tests if formal testing is performed. |
| 6 | Assess missing-data assumptions | Determine how incomplete laboratory follow-up affects the analysis. |
| 7 | Interpret clinical relevance | Distinguish numerical laboratory change from clinically meaningful safety findings. |
This framework explains the statistical workflow without attributing a specific model or result to BORA that is absent from the ClinicalTrials.gov record.
23. Related Tutorials
Learn more about the methods used in this trial:
24. Related Statistical Calculators
25. Sources
- ClinicalTrials.gov: BORA — NCT02258542.
- Linked publication: PubMed PMID 33609624.
- Linked publication: PubMed PMID 30416083.
Continue through Clinical Biostats
Use the broader tutorial and calculator collections to explore randomized trial design, laboratory endpoints, and the statistical principles used to interpret clinical-study data.
26. Record Summary
BORA is a completed randomized, double-masked, parallel phase 3 study in asthma with 2133 enrolled participants and 2 arms. Its 16 registered primary endpoints are laboratory change-from-baseline measures evaluated at Week 56 and, for specified adolescents from SIROCCO/CALIMA, Week 108. Results were posted for the registered primary endpoints, but the ClinicalTrials.gov record contains no formal treatment-comparison estimates, confidence intervals, or p-values.
The central statistical lesson is therefore methodological rather than numerical. BORA illustrates how a trial can combine randomization and masking with continuous laboratory safety endpoints, multiple primary measures, distinct analysis populations, and an extension-study population selected through predecessor-study participation. The registry's explicit warning about selection bias and its definition of baseline are particularly important when interpreting change-from-baseline laboratory data.