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 Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma (NCT00425555), a non-randomized phase 2 study. The primary outcome is Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00425555 |
| Phase | Phase 2 |
| Condition | Cutaneous T-Cell Lymphoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 139 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Adults with refractory cutaneous T-cell lymphoma were enrolled. The registry describes the primary analysis population as the Full Analysis Set, defined according to the intention-to-treat principle and including all participants enrolled. Total enrollment was 139.
Intervention
Participants received oral panobinostat, described as 20 milligrams per day in capsule form, once a day on 3 days per week. The listed schedule was Monday, Wednesday and Friday, or alternative Day 1, 3 and 5.
Comparator
The registry separates participants by prior oral bexarotene treatment: previously treated and no prior oral bexarotene treatment. Both groups received the same panobinostat regimen. Allocation was non-randomized, so these groups are not a like-for-like control comparison.
Primary question
The primary endpoint was the overall response rate assessed with the modified Severity-Weighted Assessment Tool, or mSWAT, from baseline up to 6 months of follow-up. The registry record does not report the response-rate estimate or its 95% confidence interval, so the primary endpoint result cannot be described from the registry record.
The clinical question is therefore about the response rate observed during treatment in this enrolled population, with skin response classified using mSWAT and a requirement for documented stable disease or better in lymph node or visceral disease. It is not a randomized comparison of panobinostat against another treatment or against no treatment. The prior-bexarotene groups distinguish treatment history, rather than assigning participants to different study regimens. The registry also lists secondary outcomes covering response, time-to-event outcomes, quality-of-life measures and plasma concentration. Their outcome names do not establish what results were observed. Detailed results for those outcomes are not reported in the registry record.
3. Trial Design
This was a Phase II, parallel, non-randomized study with no masking. The registry lists enrollment of 139 adults with refractory cutaneous T-cell lymphoma. The study is marked completed. Its recorded start was 2007-01, and primary completion was recorded as 2013-06. The sponsor listed in the registry record is Novartis Pharmaceuticals.
The two groups were defined by whether participants had previously received oral bexarotene. One group was described as previously treated with oral bexarotene; the other had no prior oral bexarotene treatment. Both groups received oral panobinostat at 20 milligrams per day, once a day on 3 days per week. The schedule was Monday, Wednesday and Friday or alternative Day 1, 3 and 5. Because treatment history defined the groups and allocation was non-randomized, differences between their outcomes would not by themselves establish that prior bexarotene caused any difference. The groups may differ in ways the registry record does not describe.
A parallel design means participants are considered within their assigned or defined group over the study rather than being described as switching between treatment regimens. Here, however, the record does not describe random assignment; the group distinction is prior bexarotene exposure. The registry record does not report a separate control treatment, a masking procedure, or a randomized allocation process.
The registry record gives the overall enrollment and group-specific safety counts, but it does not report the number included in the primary response analysis or the number of response events. It also does not report details of the treatment duration, adherence, dose modifications, or discontinuations. Those omissions limit how fully the conduct and analysis can be reconstructed. The phase, allocation, masking, parallel model and treatment histories define the broad design, but they do not reveal the statistical plan or the observed clinical findings.
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: A total 139 Participants were enrolled in the Study. No Patients completed treatment. All patients discontinued the treatment on this study and 136 patients discontinued the study (97.8%). The remaining three patients discontinued the study treatment were immediately transferred to another program.
Overall Study
| Stage | Bexarotene Exposed | Bexarotene Naive |
|---|---|---|
| STARTED | 79 | 60 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 79 | 60 |
Reasons for not completing this period:
| Reason | Bexarotene Exposed | Bexarotene Naive |
|---|---|---|
| Withdrawal by Subject | 11 | 8 |
| Lost to Follow-up | 0 | 1 |
| Administrative problems | 3 | 0 |
| Death | 1 | 2 |
| New cancer therapy | 2 | 1 |
| Disease progression | 36 | 33 |
| Adverse Event | 25 | 15 |
| Protocol Violation | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the 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.
Population: The analysis was performed in Full analyses set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
| Characteristic | Unit | Bexarotene Exposed | Bexarotene Naive | Total |
|---|---|---|---|---|
| Participants analysed | 79 | 60 | 139 | |
| Age, Continuous | years | 57.9 (SD 14.70) | 62.1 (SD 11.51) | 59.7 (SD 13.53) |
| Sex: Female, Male: Female | Participants | 32 | 19 | 51 |
| Sex: Female, Male: Male | Participants | 47 | 41 | 88 |
| Race/Ethnicity, Customized: Caucasian | Participants | 68 | 54 | 122 |
| Race/Ethnicity, Customized: Black | Participants | 3 | 3 | 6 |
| Race/Ethnicity, Customized: Asian | Participants | 3 | 1 | 4 |
| Race/Ethnicity, Customized: Other | Participants | 5 | 2 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT), measured over Baseline up to 6 Months of Follow up.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was overall response rate using the modified Severity-Weighted Assessment Tool, or mSWAT, from baseline up to 6 months of follow-up. The tool was developed to assess the extent of skin disease in cutaneous T-cell lymphoma. The endpoint summarizes the proportion of participants whose skin disease met the study’s response classification, rather than measuring a continuous change in symptoms or a time until an event.
The registry describes skin response categories using change in modified SWAT score compared with baseline. Complete response means no evidence of skin disease. Partial response requires at least a 50% decrease. Stable disease is neither complete, partial nor progressive disease: the change is less than a 50% decrease and less than a 25% increase. Progressive disease requires at least a 25% increase. The registry adds that skin response was primarily classified using mSWAT provided there was documented evidence of stable disease or better in lymph node or visceral disease. Thus, the endpoint is not simply a skin-score classification without the stated disease-status condition.
An overall response rate is useful as a compact summary of how many participants satisfy the response definition during the assessment period. The registry specifies a 95% confidence interval, which would communicate uncertainty around the estimated rate. The estimate and interval themselves are not reported in the registry record. The endpoint definition alone cannot show how many participants responded, how precise the estimate was, or whether the observed pattern differed by prior bexarotene history.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies overall response rate by mSWAT as the primary outcome, but it does not report an observed response-rate estimate, a confidence interval, or a primary outcome analysis. Consequently, the primary clinical result cannot be quantified from the registry record. The endpoint description tells readers how response was intended to be classified; it is not evidence that any particular response occurred.
The study enrolled 139 participants and divided them by prior oral bexarotene treatment, with both groups receiving the same panobinostat regimen. These are not randomized treatment arms. Any contrast between the groups would mix the association with prior treatment history and other possible differences between the participants. The record does not report a causal comparison, and the design does not support treating one group as a randomized control for the other.
The registry lists secondary outcomes that include overall response rate using mSWAT, time to response among responders, duration of response, progression-free survival, Skindex-29 emotional, functioning and physical-symptom sub-scores, and maximum plasma concentration of panobinostat. It lists 13 outcome measures, but does not report outcome estimates or analysis results for these measures. Outcome names indicate what was planned for assessment, not what was observed. In particular, no time-to-event estimate or quality-of-life change can be inferred from the list.
Safety entries give counts by prior-bexarotene group. In the Bexarotene Exposed group, the serious-event category lists 79 at risk and 33 affected, the other-event category lists 79 at risk and 77 affected, and deaths are listed as 3. In the Bexarotene Naive group, the corresponding counts are 60 at risk and 23 affected for serious events, 60 at risk and 59 affected for other events, and 3 deaths. These are registry counts, not evidence for comparative safety: the groups were not randomized, and the record does not provide an adjusted comparison or explain the basis for a causal interpretation.
The registry lists Pyrexia and Pneumonia at 5.0% each among the top serious adverse-event terms. Thrombocytopenia, Abdominal pain, Chest pain, and General physical health deterioration are each listed at 3.8%. The registry record does not state the denominators or further analytic detail for these term percentages. They should therefore be read as reported entries, not as a complete account of all adverse events or as a basis for comparing risks between treatment histories.
Planning illustrations based on the observed effect are not reported as trial findings and should not be read as observed power. The registry record does not report the observed primary effect needed to interpret such an illustration, nor does it report the study’s own sample-size justification. The sponsor’s primary analysis results are not reported in the registry record; no recalculated estimate can replace an absent result. Overall, the record supplies design and endpoint definitions and some safety counts, but not enough outcome analysis to establish the size or precision of the response observed.
9. Statistical Methods Explained
Several statistical ideas help clarify what the registry record can and cannot establish. The explanations below are general statistical context; they do not describe an unreported analysis plan for this study.
What does an overall response rate describe?
In general, an overall response rate is a proportion: the number of participants meeting the defined response criteria relative to the analysis population. Its interpretation depends on how response is defined, which participants enter the denominator, when response is assessed, and how missing assessments are handled. In this study, the registry identifies mSWAT response from baseline up to 6 months of follow-up and describes the Full Analysis Set as including all enrolled participants. It does not report the response count, the resulting rate, or the handling of participants without an assessable response.
The classification rules matter because they determine which observed score changes count as complete response, partial response, stable disease or progressive disease. The registry defines those categories by comparison with baseline modified SWAT score and adds the condition of documented stable disease or better in lymph node or visceral disease. Readers should not substitute a different threshold or treat every skin-score change as a response.
What does a confidence interval communicate?
In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the method used. An interval around a response rate would indicate a range of values compatible with the data and method, rather than a guarantee that the true value lies in that range. A narrower interval generally indicates greater precision than a wider interval, while neither width nor placement establishes clinical importance by itself. Although the registry specifies a 95% confidence interval for the primary endpoint, it does not report the interval or the response-rate estimate. Precision therefore cannot be evaluated from the registry record.
Why does non-random allocation matter?
In general, random allocation helps balance measured and unmeasured characteristics across treatment groups on average. It supports a stronger interpretation of between-group differences as related to assigned treatment, subject to other design and analysis assumptions. This study was non-randomized, and its groups were defined by prior oral bexarotene history. Both received the same listed panobinostat schedule. The groups are therefore not a like-for-like control comparison. Differences in their outcomes, if reported, could reflect participant characteristics, treatment history or other factors, as well as chance. The registry record does not describe adjustment methods that would address these possibilities.
What do the analysis population and intention-to-treat wording imply?
In general, an intention-to-treat approach seeks to retain participants in the analysis according to their original study group, rather than excluding them because of events after enrollment. The registry describes the Full Analysis Set as defined according to the intention-to-treat principle and including all participants enrolled. That description identifies the intended population concept, but it does not establish the number actually analyzed for the primary endpoint. Nor does it explain how missing response assessments, withdrawals, protocol deviations or deaths were handled in that analysis. Those details are not reported in the registry record.
How should outcome multiplicity be considered?
In general, testing or estimating many outcomes can create multiple opportunities to observe apparently notable results. A statistical plan may designate one primary outcome and specify how secondary outcomes are interpreted or how multiplicity is addressed. The registry names a primary response endpoint and lists a range of secondary outcomes, including response, time-to-event, quality-of-life and pharmacokinetic measures. It does not report a multiplicity procedure, a hierarchy among secondary outcomes, or the analysis results. A multiplicity adjustment or testing strategy should not be presumed.
What does a planning illustration mean?
In general, sample-size planning uses assumptions about the effect to detect, the significance level, allocation and statistical method to estimate the number of participants or events that would be needed for a target power. A planning illustration based on an observed effect is a retrospective calculation under specified assumptions; it is not the study’s original design rationale and is not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Time-to-event illustrations express total events; other illustrations express participants per arm. The registry record does not report the study’s own sample-size justification, and the primary observed effect is not reported in the registry record. No planning illustration can substitute for the missing primary estimate or be interpreted as evidence that the study had a particular achieved power.
Why can event counts be hard to compare?
In general, counts depend on the number of participants observed, the length of follow-up, event definitions, and how repeated events are counted. A count alone does not establish the rate of events per unit of follow-up or the comparative risk between groups. The safety entries provide numbers at risk and affected in categories, plus deaths, but do not report all details needed to reconstruct follow-up-adjusted rates or comparisons. The non-randomized grouping also limits causal interpretation. These general considerations apply even when a registry reports percentages for selected serious-event terms.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary endpoint: overall response rate using mSWAT from baseline up to 6 months of follow-up. It also lists secondary outcomes covering response, time to response, duration of response, progression-free survival, Skindex-29 sub-scores for emotions, functioning and physical symptoms, and maximum plasma concentration of panobinostat. The record lists 13 outcome measures overall. However, it does not report analysis results for these outcomes; the analysis count is 0.
When a study evaluates several outcomes, general statistical practice may use a prespecified hierarchy or multiplicity adjustment to control how results are interpreted across analyses. The registry record does not report whether such a strategy was used, how secondary outcomes were prioritized, or how multiple time points or measures were handled. No specific multiplicity approach should be inferred from the outcome list.
The Full Analysis Set is described according to the intention-to-treat principle and as including all participants enrolled. The registry record does not report the number analyzed for the primary endpoint, the number with missing outcome assessments, or how missing observations were handled. It does not describe imputation, sensitivity analyses, reasons for missingness, or handling of participants who discontinued or died before assessment. These omissions prevent assessment of whether missing data could affect the response estimate.
The record also does not report the statistical model, covariate adjustment, subgroup analysis plan, interim analyses, or sample-size justification. These are not assumed. The endpoint definition and analysis-population description are useful, but they are not a substitute for a full statistical analysis plan or posted outcome results.
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 |
|---|---|---|---|
| Bexarotene Exposed | 33 | 79 | 41.8% |
| Bexarotene Naive | 23 | 60 | 38.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bexarotene Exposed | 3 of 79 |
| Bexarotene Naive | 3 of 60 |
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 |
|---|---|
| Bexarotene Exposed | 77 of 79 |
| Bexarotene Naive | 59 of 60 |
Most frequent serious adverse event terms
| Event term | Organ system | Bexarotene Exposed | Bexarotene Naive |
|---|---|---|---|
| Pyrexia | General disorders | 3 of 79 | 3 of 60 |
| Thrombocytopenia | Blood and lymphatic system disorders | 3 of 79 | 2 of 60 |
| Angina pectoris | Cardiac disorders | 2 of 79 | 1 of 60 |
| Abdominal pain | Gastrointestinal disorders | 3 of 79 | 0 of 60 |
| Asthenia | General disorders | 1 of 79 | 2 of 60 |
| Chest pain | General disorders | 3 of 79 | 0 of 60 |
| General physical health deterioration | General disorders | 3 of 79 | 0 of 60 |
| Pneumonia | Infections and infestations | 0 of 79 | 3 of 60 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 79 | 0 of 60 |
| Lymphadenopathy | Blood and lymphatic system disorders | 0 of 79 | 2 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bexarotene Exposed | Bexarotene Naive |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 45 of 79 | 38 of 60 |
| Thrombocytopenia | Blood and lymphatic system disorders | 40 of 79 | 23 of 60 |
| Fatigue | General disorders | 26 of 79 | 29 of 60 |
| Nausea | Gastrointestinal disorders | 32 of 79 | 22 of 60 |
| Pruritus | Skin and subcutaneous tissue disorders | 32 of 79 | 16 of 60 |
| Decreased appetite | Metabolism and nutrition disorders | 19 of 79 | 17 of 60 |
| Asthenia | General disorders | 22 of 79 | 10 of 60 |
| Headache | Nervous system disorders | 16 of 79 | 12 of 60 |
| Dysgeusia | Nervous system disorders | 13 of 79 | 12 of 60 |
| Neutropenia | Blood and lymphatic system disorders | 14 of 79 | 10 of 60 |
Serious events with the highest arm-level rate: pyrexia (5.0%), pneumonia (5.0%), thrombocytopenia (3.8%), abdominal pain (3.8%), chest pain (3.8%).
The registry safety entries are grouped by prior oral bexarotene history. For Bexarotene Exposed, the serious adverse-event category lists 79 at risk and 33 affected; the other adverse-event category lists 79 at risk and 77 affected; deaths are listed as 3. For Bexarotene Naive, the corresponding serious-event counts are 60 at risk and 23 affected, the other-event counts are 60 at risk and 59 affected, and deaths are listed as 3.
These counts describe the registry entries; they do not establish that one group had greater or lower risk. The groups were non-randomized and differed by prior treatment history. The record does not give an adjusted comparison, explain event follow-up in detail, or state the denominator and calculation basis for the listed percentages by serious-event term. Counts of affected participants also do not, on their own, describe event severity, duration, recurrence or exposure-adjusted frequency.
The top serious-event terms are Pyrexia and Pneumonia at 5.0% each. Thrombocytopenia, Abdominal pain, Chest pain, and General physical health deterioration are each reported at 3.8%. These entries are selected terms, not a complete account of the study’s safety experience. The listed deaths are counts and are not attributed to a cause in the registry record. No causal conclusion about treatment can be drawn from these safety figures alone.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a Phase II study enrolled 139 adults with refractory cutaneous T-cell lymphoma and evaluated oral panobinostat in groups defined by previous oral bexarotene treatment. Both groups received the same listed panobinostat regimen. The primary endpoint was an mSWAT-based overall response rate through 6 months of follow-up, with a stated 95% confidence interval and a response definition tied to baseline skin score and documented disease status in lymph node or visceral disease.
The record does not report the primary response rate, its confidence interval, or secondary outcome estimates. Thus, the statistical evidence for the primary question cannot be assessed from the registry record. The endpoint definition cannot show the number of responders, the precision of an estimate, or whether response differed between the groups. The secondary outcome list likewise cannot establish an observed effect on time to response, duration of response, progression-free survival, Skindex-29 measures or plasma concentration.
The study design also limits what a between-group contrast could mean. Participants were not randomized, and the groups reflect prior bexarotene exposure rather than different assigned study treatments. Both groups received panobinostat. Any outcome difference between groups would not isolate a causal effect of prior bexarotene or establish a randomized comparison of treatments.
The safety entries report affected-participant counts and selected serious-event terms, but do not constitute a full comparative safety analysis. The registry record does not report details needed to assess event rates over time, attribute deaths, or account for possible differences between the groups. The figures should be treated as descriptive registry data. They do not determine whether a treatment is beneficial or harmful, and they do not provide medical guidance.
In short, the record permits a description of the study design, intended endpoint and some safety entries. It does not permit a quantitative conclusion about the primary response result or the precision of that result. Missing registry results should not be interpreted as evidence of either a favorable or an unfavorable outcome.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it separates an endpoint definition from an endpoint result. The registry provides a detailed description of how skin response was classified with mSWAT, including thresholds relative to baseline and a condition concerning lymph node or visceral disease. Yet no primary response estimate or confidence interval is reported in the registry record. Knowing the measurement rule is important, but it does not establish how participants fared.
The design also demonstrates why group labels require careful interpretation. Prior oral bexarotene history defined the two groups, while both received the same panobinostat schedule. Non-random allocation means these groups are not interchangeable control groups. A simple difference in observed outcomes, if available, would need to be interpreted in light of possible baseline and treatment-history differences. The registry record does not report a causal comparative analysis.
The number of listed outcome measures makes the distinction between primary and secondary outcomes relevant. Overall response rate was designated primary, while the secondary outcomes span response timing and duration, progression-free survival, quality-of-life measures and plasma concentration. General statistical practice distinguishes a prespecified primary question from exploratory or secondary findings and considers how multiple analyses affect interpretation. The registry record does not report its multiplicity strategy or the analysis results.
Finally, safety counts illustrate why denominators, follow-up and event definitions matter. The record lists participants at risk and affected in broad categories and names selected serious-event terms, but does not provide the fuller context needed for adjusted or exposure-based comparisons. Statistical reading requires attention not only to the numbers that are present, but also to the design and analysis details that are absent. Here, the record supports a methodological description, not a numerical conclusion about the primary response outcome.
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 main limitation for interpreting efficacy is that the registry record does not report the primary endpoint estimate or its 95% confidence interval. It also does not report the participant count analyzed for that endpoint, response counts, or results for the listed secondary outcomes. The record therefore does not permit assessment of response magnitude, precision or consistency across outcomes.
The non-randomized design is a further limitation for comparisons between groups. Prior oral bexarotene history determined group membership, and the record does not describe a randomized control group. The two groups may differ in participant or disease characteristics, but those characteristics and any statistical adjustment for them are not reported in the registry record. Any group contrast would therefore require caution and would not be a randomized treatment comparison.
The registry record does not report details of treatment duration, adherence, dose changes, discontinuations, follow-up completeness, or the handling of missing primary outcome assessments. It does not report an analysis plan, interim analysis details, multiplicity procedures or the study’s sample-size justification. These omissions limit reproducibility and make it difficult to judge how planned analyses relate to the enrolled population.
Safety information is also limited in interpretability. The record gives category counts and selected serious adverse-event term percentages, but does not provide their full analytic context, event timing, exposure-adjusted rates or a comparative model. The deaths are listed as counts without attribution. These limitations are specific to what the registry record reports; they do not establish that an analysis or information was absent from other study materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma — NCT00425555.
- Registry record last updated 2021-08-20; status last verified 2021-08.
- Results first posted 2021-08-16.
- 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
The registry record describes NCT00425555, a completed Phase II, parallel, non-randomized study with no masking, enrolling 139 adults with refractory cutaneous T-cell lymphoma. Participants with and without prior oral bexarotene treatment received the same listed oral panobinostat regimen: 20 milligrams per day on 3 days per week.
The primary endpoint was mSWAT-based overall response rate from baseline up to 6 months of follow-up, with a 95% confidence interval specified. The Full Analysis Set was described as including all enrolled participants under the intention-to-treat principle. The primary estimate, confidence interval and secondary outcome analyses are not reported in the registry record. Safety entries include group-specific counts and selected serious-event terms, but do not support a causal comparison between the non-randomized groups.