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 Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (NCT00289978), a randomized phase 3 study. The primary outcome is Estimated Annualized Aggregate Relapse Rate (ARR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00289978 |
| Phase | Phase 3 |
| Condition | Relapsing-remitting Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 1272 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Novartis |
| Results posted | Yes |
2. Clinical Question
Population
Patients with relapsing-remitting multiple sclerosis were eligible for the study. The primary outcome analysis used the Intent-to-treat population, defined in the registry record as randomized patients who received at least one dose of study drug.
Intervention
The study compared two once-daily oral fingolimod regimens: 1.25 mg and 0.5 mg. The registry record describes a 24-month study period and reports the primary outcome from baseline to the end of the study.
Comparator
Both fingolimod regimens were compared with placebo in a randomized, parallel-group study. The record identifies placebo as the control group for the posted primary and secondary outcome summaries.
Primary question
The primary question was how the estimated annualized aggregate relapse rate differed across the three groups during the study. A relapse was defined using clinical criteria, including a new or worsening neurological abnormality lasting at least 24 hours and separated from a preceding relapse by at least 30 days.
The trial also assessed disability progression using the Expanded Disability Status Scale and the number of new or newly enlarged T2 lesions. These outcomes address different aspects of the disease course: relapse frequency, disability status, and MRI lesion activity. The posted summaries allow the reader to compare the observed group estimates, but the registry record does not report an inferential analysis for the primary endpoint. Consequently, the primary outcome results are best read as estimates with their confidence intervals, rather than as a complete report of a prespecified hypothesis test.
3. Trial Design
This was a randomized, triple-masked, parallel-group phase 3 study comparing oral fingolimod at 1.25 mg once daily and 0.5 mg once daily with placebo. The official title describes a 24-month, double-blind study, while the registry fields identify masking as triple. The study enrolled 1272 participants and is listed as completed. The sponsor was Novartis.
The registry record lists a start date of 2006-01 and a primary completion date of 2009-07. The primary outcome timeframe is baseline to the end of the study at Month 24. The primary analysis population is described as Intent-to-treat, including randomized patients who received at least one dose of study drug. The group summaries report 429 participants for fingolimod 1.25 mg, 425 for fingolimod 0.5 mg, and 418 for placebo. These are the denominators attached to the posted primary outcome summaries; the registry record does not explain any differences between enrollment and outcome denominators.
The primary endpoint was estimated annualized aggregate relapse rate, expressed as relapses per year. Secondary outcomes were the percentage of patients free of disability progression at Month 24 and the number of new or newly enlarged T2 lesions at Month 24 in comparison with baseline. All three groups have posted results for these outcomes. Although the record gives study design and outcome definitions, details of the randomization procedure, allocation concealment, masking roles, treatment adherence, and handling of protocol deviations are not reported in the registry record. The statistical analysis plan and a sample-size justification for the trial are also not reported in the registry record.
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 | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| STARTED | 429 | 425 | 418 |
| COMPLETED | 332 | 369 | 332 |
| NOT COMPLETED | 97 | 56 | 86 |
Reasons for not completing this period:
| Reason | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Withdrawal by Subject | 31 | 17 | 28 |
| Adverse Event | 22 | 13 | 18 |
| Lack of Efficacy | 13 | 6 | 25 |
| Abnormal laboratory value(s) | 20 | 9 | 1 |
| Lost to Follow-up | 3 | 5 | 7 |
| Protocol Violation | 5 | 5 | 4 |
| Abnormal test procedure result(s) | 2 | 1 | 1 |
| Death | 1 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 429 | 425 | 418 | 1272 | |
| Age Continuous | years | 37.4 (SD 8.91) | 36.6 (SD 8.77) | 37.2 (SD 8.60) | 37.1 (SD 8.76) |
| Age, Customized: <18 years | participants | 1 | 0 | 0 | 1 |
| Age, Customized: 18 -30 | participants | 107 | 120 | 97 | 324 |
| Age, Customized: 31-40 | participants | 147 | 162 | 165 | 474 |
| Age, Customized: 41-55 | participants | 174 | 143 | 156 | 473 |
| Sex: Female, Male: Female | Participants | 295 | 296 | 298 | 889 |
| Sex: Female, Male: Male | Participants | 134 | 129 | 120 | 383 |
| Duration of multiple sclerosis since first symptoms | Years | 8.4 (SD 6.86) | 8.0 (SD 6.60) | 8.1 (SD 6.35) | 8.2 (SD 6.60) |
| Number of relapses in last 2 years | relapses | 1.5 (SD 0.81) | 1.5 (SD 0.76) | 1.4 (SD 0.73) | 1.5 (SD 0.77) |
| Expanded Disability Status Scale (EDSS) | Units on a scale | 2.41 (SD 1.36) | 2.30 (SD 1.29) | 2.49 (SD 1.29) | 2.40 (SD 1.32) |
6. Primary Endpoint
The registry lists the primary outcome as Estimated Annualized Aggregate Relapse Rate (ARR), measured over Baseline to end of study (Month 24).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Relapses per year |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, estimated annualized aggregate relapse rate, is a rate measure: it describes confirmed relapses relative to time on study, expressed as relapses per year. The registry definition requires a new or worsening previously stable or improving neurological abnormality, separated from the onset of a preceding relapse by at least 30 days. The abnormality must last at least 24 hours and occur without fever or infection. These criteria distinguish a confirmed relapse from a temporary symptom change that does not meet the stated definition.
The registry record says the annualized rate for each group was the mean of the annualized rates for all patients in that group. Each patient’s rate was calculated from confirmed relapses divided by days on study and multiplied by 365.25. Annualizing expresses rates on a common time scale, which can help describe outcomes when participants have different amounts of time under observation. That is a general property of rate measures; the record does not provide participant-level follow-up distributions or explain how incomplete observations were handled.
The endpoint is used to summarize relapse frequency over the study period, rather than the timing of each relapse or the severity of each event. Its interpretation therefore depends on the clinical relapse definition and the time-at-risk information included in the calculation. The posted estimates are accompanied by 95% confidence intervals, which describe statistical uncertainty around each group estimate under the analysis used. The registry record does not report a primary endpoint comparison estimate, a p-value, or a detailed statistical model.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The estimated annualized aggregate relapse rate was 0.16 relapses per year for fingolimod 1.25 mg, with a 95% confidence interval from 0.13 to 0.19. For fingolimod 0.5 mg, the estimate was 0.18, with a 95% confidence interval from 0.15 to 0.22. For placebo, it was 0.4, with a 95% confidence interval from 0.34 to 0.47. The posted point estimates are lower in both fingolimod groups than in the placebo group. These summaries describe the registry results; they do not by themselves establish the statistical significance or clinical importance of a between-group difference.
A confidence interval gives a range of values compatible with the data and the method used to calculate the interval. It conveys uncertainty about each group’s estimated rate, not a direct interval for the difference between groups. The registry record does not give a confidence interval for either primary comparison, nor does it give a p-value or identify a model for those comparisons. Comparing the group intervals by inspection is not a substitute for a direct comparison analysis.
The secondary outcome summaries have a broadly concordant descriptive pattern: the fingolimod groups have higher estimates for being free of disability progression and lower mean counts of new or newly enlarged T2 lesions than placebo. Those outcomes measure different features from the relapse-rate endpoint, and their summaries should not be treated as a replacement for the primary endpoint analysis. The registry record lists no reported analyses for the secondary outcomes. The posted comparisons are unadjusted re-calculations, and their p-values do not account for the multiple outcomes and comparisons in the record. They are therefore more appropriately interpreted as exploratory than as definitive confirmatory evidence.
For the primary endpoint, the registry supplies group estimates and confidence intervals but no reported analysis of treatment contrasts. The record also does not state whether the primary analysis adjusted for baseline characteristics, accounted for repeated events in a particular way, or used any particular distributional assumptions beyond the endpoint definition. Such details matter because relapse events are counts accumulated over time and participants may have different numbers of events and follow-up durations. The registry data do not permit those analytical choices to be reconstructed.
The posted data therefore support a careful descriptive conclusion: the recorded group estimates differ, and uncertainty is visible in the reported intervals. The completeness of that comparison is limited by the absence of a reported primary contrast and analysis method. Nothing in these summaries alone establishes why the groups differed, how robust the findings are to other reasonable analyses, or what an individual patient’s outcome would be.
9. Statistical Methods Explained
The statistics in the registry describe several kinds of outcomes. The primary measure is a rate, the disability outcome is a percentage, and the lesion outcome is a count summarized by its mean and standard deviation. These quantities answer different questions, so their estimates and uncertainty should be interpreted on their own scales. General statistical explanations below describe those concepts; they do not add analyses beyond what the registry record reports.
What does a confidence interval describe?
A confidence interval expresses the uncertainty around an estimate under a specified statistical procedure. A narrower interval indicates greater precision under that procedure; a wider interval indicates less precision. The primary relapse-rate estimates have 95% confidence intervals. The registry record does not describe the method used to construct them, so the intervals can be reported as posted but their exact modeling assumptions cannot be assessed from the record. A group-specific interval also differs from a confidence interval for a contrast between groups. To quantify the uncertainty in a treatment contrast directly, the analysis needs to estimate that contrast and its uncertainty.
Why is an annualized rate different from a simple count?
A count records the number of events, whereas a rate relates events to time at risk. The endpoint definition states that confirmed relapses were divided by days on study and multiplied by 365.25 to express the result per year. This approach is intended to put observation time on a common scale. In general, rate analyses need an appropriate account of differences in follow-up and event occurrence. The registry record defines the calculation but does not report the individual follow-up data, the distribution of relapse counts, or further modeling details. It is therefore not possible to determine from the registry summary whether any particular count model or adjustment for over-dispersion was used. In general, over-dispersion means that observed event counts vary more than a chosen model expects; ignoring it can make uncertainty estimates too small.
How should percentages and risk differences be read?
The disability outcome is reported as the percentage of participants free of disability progression at Month 24. A percentage is a proportion expressed on a percentage scale. The posted comparisons also include unadjusted risk differences and confidence intervals. A risk difference describes the subtraction of one group’s proportion from another group’s proportion, expressed as a difference in probability. The comparison summaries give values and confidence intervals, but the registry record lists no reported analyses for this outcome. The accompanying p-values are unadjusted re-calculations, not identified as the sponsor’s prespecified analysis. They should not be interpreted as accounting for multiplicity or other potential analysis choices.
What do the lesion means and standard deviations convey?
The MRI outcome is summarized by the mean number of new or newly enlarged T2 lesions and a standard deviation for each group. A mean describes the average, while a standard deviation describes spread of individual observations around that average. A mean difference can describe a contrast between two group averages, and its confidence interval describes uncertainty around that contrast under the calculation used. The posted comparison summaries include unadjusted mean differences and p-values. The registry record does not report a sponsor analysis for this endpoint or say whether a count-specific statistical model was used. In general, count outcomes can be skewed and include many low values alongside some high values. A mean and standard deviation alone may not fully describe that distribution.
What do the planning illustrations mean?
The planning illustrations for the secondary comparisons use the observed effect or a stated fraction of it, with a two-sided significance level of 0.05, equal allocation between the compared groups, and a normal approximation. They estimate participants per arm for 80% or 90% power under those assumptions. These are planning illustrations, not observed power and not the sample-size rationale for the completed trial. The registry record does not report the trial’s own sample-size justification. Planning estimates based on an observed effect can be optimistic because the effect estimate itself is uncertain; reducing the assumed effect in an illustration shows how required sample size can change when the effect to detect is smaller.
The registry record lists zero reported analyses for the primary outcome and no reported analyses for the posted secondary outcomes. Consequently, the posted group summaries and the unadjusted re-calculations do not reveal the sponsor’s full prespecified inferential approach. The exact handling of missing outcomes, protocol deviations, repeated events, and multiple testing is not reported in the registry record. A general principle is that these choices can affect both estimates and uncertainty. Without the protocol or analysis plan, readers should avoid treating re-calculated comparisons as equivalent to a complete trial analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan, a multiplicity strategy, or interim analyses. It also lists no reported analyses for the primary outcome and no reported analyses for the secondary outcomes. The posted unadjusted re-calculations therefore should not be assumed to represent the study’s prespecified testing procedure. If multiple outcomes or contrasts are tested, multiplicity can increase the likelihood of a nominally small p-value arising by chance. A prespecified hierarchy or an adjustment can address that issue, but whether either approach was used is not reported in the registry record.
Missing-data handling is also not reported in the registry record. The primary analysis population is defined as randomized patients who received at least one dose of study drug, but that definition does not explain how missing relapse information, incomplete follow-up, or unavailable Month 24 secondary outcomes were handled. The record does not describe imputation, censoring, sensitivity analyses, or how participants who discontinued treatment were included in follow-up. The number of participants attached to each outcome summary is stated, but the record does not explain the relationship between those denominators, enrollment, and any missing observations.
For the primary outcome, the stated population is an Intent-to-treat population with the additional condition of at least one dose. This description is important because it defines who was included in that analysis, but it is not enough to reconstruct the full analysis set or analysis method. The populations used for the secondary outcomes are not reported in the registry record. No conclusion about the effect of missing data or deviations from assigned treatment can be drawn from the posted summaries alone.
In general, missingness and multiplicity affect how confidently estimates can be generalized beyond the observed summaries. If the likelihood of missing data is related to outcome or treatment experience, a complete-case summary may not represent all randomized participants. That is a general concern, not evidence that such bias occurred in this trial. The registry record lacks the information needed to assess it.
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 |
|---|---|---|---|
| Fingolimod 1.25 mg | 51 | 429 | 11.9% |
| Fingolimod 0.5 mg | 43 | 425 | 10.1% |
| Placebo | 56 | 418 | 13.4% |
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 |
|---|---|
| Fingolimod 1.25 mg | 346 of 429 |
| Fingolimod 0.5 mg | 355 of 425 |
| Placebo | 323 of 418 |
Most frequent serious adverse event terms
| Event term | Organ system | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|---|
| Bradycardia | Cardiac disorders | 3 of 429 | 4 of 425 | 1 of 418 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 429 | 4 of 425 | 2 of 418 |
| Multiple sclerosis relapse | Nervous system disorders | 3 of 429 | 2 of 425 | 1 of 418 |
| Non-cardiac chest pain | General disorders | 0 of 429 | 2 of 425 | 2 of 418 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 429 | 0 of 425 | 3 of 418 |
| Macular oedema | Eye disorders | 3 of 429 | 0 of 425 | 0 of 418 |
| Liver function test abnormal | Investigations | 2 of 429 | 0 of 425 | 1 of 418 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 429 | 2 of 425 | 1 of 418 |
| Syncope | Nervous system disorders | 1 of 429 | 1 of 425 | 1 of 418 |
| Abortion | Pregnancy, puerperium and perinatal conditions | 0 of 429 | 0 of 425 | 3 of 418 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 112 of 429 | 115 of 425 | 115 of 418 |
| Headache | Nervous system disorders | 113 of 429 | 107 of 425 | 96 of 418 |
| Upper respiratory tract infection | Infections and infestations | 62 of 429 | 73 of 425 | 72 of 418 |
| Fatigue | General disorders | 46 of 429 | 48 of 425 | 45 of 418 |
| Influenza | Infections and infestations | 40 of 429 | 55 of 425 | 41 of 418 |
| Back pain | Musculoskeletal and connective tissue disorders | 45 of 429 | 49 of 425 | 28 of 418 |
| Diarrhoea | Gastrointestinal disorders | 40 of 429 | 50 of 425 | 30 of 418 |
| Cough | Respiratory, thoracic and mediastinal disorders | 37 of 429 | 43 of 425 | 34 of 418 |
| Nausea | Gastrointestinal disorders | 38 of 429 | 38 of 425 | 36 of 418 |
| Alanine aminotransferase increased | Investigations | 49 of 429 | 42 of 425 | 16 of 418 |
Serious events with the highest arm-level rate: bradycardia (0.9%), basal cell carcinoma (0.9%), breast cancer (0.7%), abortion (0.7%), macular oedema (0.7%).
The registry safety summary lists participants affected by serious adverse events and other adverse events by group. For fingolimod 1.25 mg, the serious adverse event count is 51 among 429 at risk, and the other adverse event count is 346 among 429 at risk. For fingolimod 0.5 mg, the corresponding counts are 43 among 425 and 355 among 425. For placebo, they are 56 among 418 and 323 among 418. These are reported counts with their stated group denominators; no additional rates are calculated.
The record also lists serious adverse event terms, including bradycardia, basal cell carcinoma, breast cancer, abortion, macular oedema, and multiple sclerosis relapse, with percentages attached to each term. Those term percentages are listed without an arm assignment in the registry summary, so they should not be attributed to a particular group. The record does not explain whether participants could contribute to more than one term or provide further context for these percentages.
Deaths are not reported in the registry record. The serious adverse event counts alone do not establish causality, comparative risk, or the clinical significance of an individual event. The record does not provide a detailed adverse-event analysis plan, severity breakdown, or exposure-adjusted safety comparison. These summaries describe what is posted, but they are not a complete assessment of safety.
12. What the Result Does, and Does Not, Mean
The posted results show group-level estimates for relapse rate, disability progression status, and MRI lesion counts over a study described as lasting 24 months. The primary relapse-rate point estimates are lower in both fingolimod groups than in the placebo group, and the group-specific confidence intervals communicate uncertainty around those estimates. The secondary summaries have a directionally similar pattern across their respective measures. These statements describe the registry results; they do not establish a clinical recommendation or determine what would happen to an individual participant.
The distinction between description and inference matters. A difference between posted point estimates is not, by itself, proof that the groups differ beyond chance. For the primary endpoint, the registry record does not report a direct comparison estimate, its confidence interval, or a p-value. The secondary comparison calculations are unadjusted and have no reported sponsor analyses in the registry record. They therefore cannot resolve all questions about statistical significance, multiplicity, analysis choices, or robustness.
The estimates also do not explain why outcomes differed. The registry summaries do not provide participant-level information, detailed baseline characteristics, adherence, or the distribution of follow-up. Nor do they explain missing-data handling or the relationship between the primary and secondary outcomes. Without those details, readers cannot assess whether important prognostic differences or analysis decisions could influence the summaries.
Confidence intervals are not guarantees about the range of individual outcomes, and group averages do not describe every participant’s experience. Similarly, the planning illustrations are hypothetical calculations under stated assumptions and are not evidence of the trial’s observed power or a record of the original design rationale. The most defensible interpretation is limited to the posted group summaries and their reported uncertainty, with the absent analysis details kept in view.
13. Why This Trial Matters Statistically
This trial is statistically informative because it reports a rate-based primary outcome alongside outcomes measured as a percentage and a count. Those forms require different interpretations. The relapse endpoint relates events to time on study, the disability endpoint describes the proportion free of progression at a specified time, and the MRI endpoint summarizes lesion counts. Understanding the scale and definition of each outcome is necessary before comparing estimates or discussing their uncertainty.
The study also illustrates why group summaries are not a complete inferential report. The primary endpoint includes estimates and confidence intervals for each arm, but the registry record does not provide the treatment contrasts or the statistical analysis used to test them. For the secondary outcomes, unadjusted re-calculations can help readers understand the scale and direction of observed contrasts, while still falling short of a prespecified analysis with a stated multiplicity strategy. Statistical interpretation depends not only on the numerical estimates but also on how the analysis was planned and conducted.
Finally, the registry record separates the information that is available from what remains unknown. It defines the primary relapse outcome and its analysis population, and it provides group-level results and safety counts. But it does not report the analysis plan, missing-data procedures, sample-size justification, or detailed safety comparisons. Recognizing these boundaries is a central biostatistical skill: numerical results can be useful without supporting conclusions beyond their design, definitions, and reporting context.
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.
Several trial-specific limitations follow from the level of detail in the registry record. The primary outcome is described as an annualized aggregate relapse rate, but no direct comparison of the treatment groups is reported. The record does not identify the model used for recurrent relapses, explain how time at risk was handled beyond the endpoint formula, or report whether the interval estimates account for within-participant event patterns. This leaves the primary group estimates interpretable descriptively but limits reconstruction of the inferential analysis.
The registry lists two secondary outcomes and group summaries, but it does not report sponsor analyses for them or a multiplicity strategy. The record also does not state the analysis populations for the secondary outcomes. The disability endpoint is a percentage at Month 24, and the MRI endpoint is a mean and standard deviation for lesion counts; neither summary alone gives the full outcome distribution. In general, count distributions can be skewed, but the record does not provide enough detail to determine whether that issue materially affects this endpoint’s analysis.
Important operational information is absent. Randomization procedures, allocation concealment, treatment adherence, protocol deviations, missing-data handling, and the sample-size justification are not reported in the registry record. The reported enrollment and outcome denominators are not accompanied by an explanation of participant flow or reasons for any difference. Deaths are not reported in the registry record, and the serious adverse event term percentages are not assigned to specific groups in the posted summary. These gaps limit assessment of precision, bias, and the completeness of the safety picture; they do not establish that any specific problem occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis — NCT00289978.
- Registry record last updated 2012-04-11; status last verified 2012-04.
- Results first posted 2011-03-16.
- 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 a completed randomized, triple-masked, parallel-group phase 3 study of oral fingolimod 1.25 mg, fingolimod 0.5 mg, and placebo in patients with relapsing-remitting multiple sclerosis. Enrollment was 1272. The primary outcome was estimated annualized aggregate relapse rate from baseline to the end of the study at Month 24, analyzed in an Intent-to-treat population defined as randomized participants who received at least one dose.
Posted primary estimates are 0.16 for fingolimod 1.25 mg, 0.18 for fingolimod 0.5 mg, and 0.4 for placebo, each with a 95% confidence interval. The registry also posts disability progression and T2 lesion outcomes, along with adverse-event counts. It does not report the primary inferential comparison, sponsor analyses for the secondary outcomes, the statistical analysis plan, missing-data procedures, or the trial’s sample-size justification. The available results support descriptive comparisons, with those reporting gaps limiting stronger statistical interpretation.