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 Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis (NCT00803049), a randomized phase 3 study. The primary outcome is Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00803049 |
| Phase | Phase 3 |
| Condition | Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 742 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
Participants with multiple sclerosis who had completed treatment in the EFC6049 study and entered its long-term extension. The registry describes the safety population as participants randomized in LTS6050 who were exposed to investigational medicinal product during its treatment period. The registry enrollment is 742, but the safety figures are reported separately by treatment sequence.
Intervention
Teriflunomide taken once daily at 7 mg or 14 mg during the extension. The record describes an extension treatment period of 288 weeks for each sequence receiving teriflunomide.
Comparator
The extension groups are treatment sequences, not continuing placebo controls. Some participants received placebo during EFC6049 and then teriflunomide in the extension; others received teriflunomide in both periods. The registry does not report a placebo-only extension group.
Primary question
What proportion of participants experienced at least one treatment-emergent adverse event during the defined on-treatment period? The record’s primary objective was to document long-term safety and tolerability. The primary endpoint is an overall adverse-event measure, not a test of whether treatment caused each event.
The record also lists secondary efficacy outcomes involving sustained disability progression, relapse rate, and MRI lesion volume. Those outcomes address different questions and should not be treated as substitutes for the primary safety endpoint. The registry record does not report a primary endpoint comparison or an inferential result for this endpoint.
3. Trial Design
This is a phase 3, randomized, double-blind, parallel-group study record for a long-term extension of EFC6049. The extension title identifies its purpose as documenting the safety of two teriflunomide doses in people with multiple sclerosis with relapses. The registry lists 742 participants as enrolled and marks the study completed. The study start is recorded as 2006-10 and primary completion as 2015-12.
The treatment groups represent sequences across the parent study and extension. Participants who had received placebo for 108 weeks in EFC6049 entered the extension on either teriflunomide 7 mg or 14 mg once daily for 288 weeks. Participants who had received teriflunomide 7 mg or 14 mg in EFC6049 continued the same dose for 288 weeks in the extension. Thus, the group labels encode prior treatment as well as extension treatment.
This structure matters for interpretation. The placebo period belongs to the earlier study; the extension descriptions state that participants in those sequences received teriflunomide during the extension. The record therefore does not describe a concurrent placebo comparison throughout the extension. It also does not report enough information to establish which comparisons were prespecified for the primary endpoint or how the extension’s treatment assignments were made beyond the registry’s randomized designation.
The primary objective was long-term safety and tolerability. The listed secondary objectives concerned disability progression, relapse rate, and MRI measures. The registry record does not report the protocol’s sample-size justification, details of any interim analyses, or the full statistical analysis plan.
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: Participants who received placebo in EFC6049 study were randomized in 1:1 ratio to receive either teriflunomide 7 mg/day or 14 mg/day and, those who received teriflunomide 7 mg/day or 14 mg/day in EFC6049 (NCT00134563) received same double-blind treatment in this extension study.
Overall Study
| Stage | Placebo/Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg |
|---|---|---|---|---|
| STARTED | 129 | 252 | 108 | 253 |
| Treated | 129 | 252 | 108 | 251 |
| Safety Population | 129 | 254 | 107 | 250 |
| COMPLETED | 68 | 134 | 64 | 151 |
| NOT COMPLETED | 61 | 118 | 44 | 102 |
Reasons for not completing this period:
| Reason | Placebo/Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg |
|---|---|---|---|---|
| Adverse Event | 21 | 33 | 13 | 27 |
| Lack of Efficacy | 10 | 19 | 6 | 13 |
| Lost to Follow-up | 0 | 2 | 0 | 3 |
| Death | 2 | 1 | 0 | 2 |
| Progressive Disease | 6 | 10 | 6 | 6 |
| Withdrawal by Subject | 19 | 43 | 16 | 44 |
| Protocol Violation | 0 | 1 | 1 | 0 |
| Randomized and Not Treated | 0 | 0 | 0 | 2 |
| Other than Specified Above | 3 | 9 | 2 | 5 |
Analysis population for the primary outcome, as defined in the registry: Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.
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 | Placebo/Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 129 | 252 | 108 | 253 | 742 | |
| Age, Continuous | years | 39.6 (SD 8.5) | 38.0 (SD 8.8) | 37.6 (SD 8.5) | 38.6 (SD 8.4) | 38.4 (SD 8.6) |
| Gender: Female | Participants | 94 | 175 | 85 | 182 | 536 |
| Gender: Male | Participants | 35 | 77 | 23 | 71 | 206 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), measured over Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with treatment-emergent adverse events, or TEAEs. The registry defines an adverse event as an untoward medical occurrence in someone who received investigational medicinal product, regardless of whether a causal relationship with treatment was considered possible. A TEAE is an event that developed, worsened, or became serious during the specified on-treatment period.
The period starts with the first study-drug dose in LTS6050 and extends to 4 weeks, or 28 days, after the last dose. The stated timeframe is baseline in LTS6050 through that post-treatment interval, up to 450 weeks. The endpoint includes both serious and non-serious events. A serious adverse event is defined by outcomes such as death, a life-threatening event, initial or prolonged inpatient hospitalization, persistent or significant disability, a congenital anomaly or birth defect, or an event considered medically important.
Counting participants with at least one event is useful for describing how commonly any qualifying event occurred in each treatment sequence. It is a broad safety measure: it does not distinguish event severity unless serious and non-serious events are reported separately, and it does not establish that treatment caused an event. The registry record does not report a primary endpoint percentage or a statistical comparison for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures describe the number of participants with serious adverse events and the number with other adverse events in each treatment sequence. For Placebo/Teriflunomide 7 mg, the serious-event count is 32 among 129 at risk, and the other-event count is 107 among 129 at risk. For Teriflunomide 7 mg/7 mg, the corresponding counts are 71 among 254 and 195 among 254. For Placebo/Teriflunomide 14 mg, they are 23 among 107 and 95 among 107. For Teriflunomide 14 mg/14 mg, they are 62 among 250 and 197 among 250.
These are descriptive counts. The registry record does not provide confidence intervals, p-values, adjusted comparisons, or a primary endpoint result that would establish a between-group difference. No statistical significance or causal effect should be inferred from differences that a reader might perceive between the displayed counts. The treatment sequences also differ in their earlier EFC6049 exposure, so the labels do not represent a simple comparison of otherwise identical groups receiving different doses throughout the entire study.
The serious adverse-event terms listed most frequently include Alanine aminotransferase increased at 3.1%, Intervertebral disc protrusion at 2.0%, Uterine leiomyoma at 1.9%, Pyelonephritis at 1.6%, Cardiac arrest at 1.6%, and Myocardial infarction at 1.2%. These are registry-listed term frequencies; they do not by themselves establish causality, comparative risk, or the clinical course of an event. The record does not supply a detailed account of how these term percentages were calculated or a comparator-specific analysis for each term.
The registry identifies the safety population as participants randomized in LTS6050 and exposed to investigational medicinal product during the treatment period, analyzed according to treatment received. That population definition is relevant when reading the counts: the record is not describing all people enrolled in the broader trial in an interchangeable way. The registry also does not report how missing safety observations were handled or whether participants with incomplete follow-up were treated differently in the analysis.
Overall, the posted results support a description of observed event counts within the stated safety population and treatment sequences. They do not provide the inferential evidence needed to determine whether event rates differed statistically between sequences, nor do they isolate the effect of teriflunomide from time on treatment, prior study treatment, or other causes of adverse events.
9. Statistical Methods Explained
The primary endpoint is a participant-level event proportion: whether a participant had at least one TEAE during the defined on-treatment period. In general, a proportion is calculated by counting participants who meet the event definition and relating that count to the participants in the relevant analysis population. A clear report should identify both the numerator and denominator, define the observation period, and state how incomplete observations are handled. The registry provides the safety population definition and the event window, but it does not report the primary endpoint’s group percentages or its statistical comparison.
What does a treatment-emergent definition mean?
In general, “treatment-emergent” is a timing classification: an event meets the endpoint definition because it develops, worsens, or becomes serious within the specified treatment-related period. The definition does not establish that the study drug caused the event. The registry explicitly defines adverse events without regard to the possibility of a causal relationship. This distinction is important in long-term safety reporting, where events can occur for reasons unrelated to treatment.
The record includes serious and non-serious TEAEs in the overall primary endpoint. It separately lists counts for serious events and other events in the posted safety data. These categories convey different aspects of safety, but they should not be added together to create an overall number: the registry does not state that the categories are mutually exclusive at the participant level, and a person may have experienced events in more than one category. Nor does the record provide a count of participants with any TEAE that could be independently checked against the primary endpoint.
How should group comparisons be assessed?
In general, comparing event proportions requires more than inspecting raw counts. The denominator, follow-up time, and analysis population all influence how the data should be read. Confidence intervals describe the uncertainty around an estimate; a narrower interval generally indicates greater precision, while a wider interval indicates less precision. A confidence interval for a difference or ratio can help assess the range of between-group values compatible with the data. The registry record does not report such intervals for the primary endpoint or state a primary group-comparison method.
Time at risk can also matter in long-term follow-up. If participants have different observation durations, a simple proportion may not reflect the same exposure opportunity for everyone. The record gives an endpoint timeframe and treatment descriptions, but does not report group-specific person-time or explain whether the primary endpoint analysis adjusted for different follow-up. No adjusted safety comparison should therefore be assumed.
What do the secondary methods imply?
The secondary outcomes name several methods. Kaplan-Meier estimates are listed for time to 12 Week Sustained Disability Progression and time to 24 Week Sustained Disability Progression. In general, the Kaplan-Meier approach estimates the probability of remaining free of an event over time while accommodating participants whose event status is not observed for the full follow-up, under assumptions about censoring. The registry does not provide the detailed analysis choices or assumptions used for these outcomes.
Annualized MS Relapse Rate is listed as a Poisson regression estimate. In general, Poisson regression models event counts in relation to a time-at-risk period. It can be useful for relapse counts, but the model’s assumptions should be checked. If the count variability is greater than the Poisson model expects, a condition called over-dispersion, standard errors and resulting uncertainty estimates can be misleading unless the analysis accounts for it. The registry record does not report whether over-dispersion was assessed or how it was addressed.
The MRI outcome is change from baseline in total volume of abnormal lesions, described as burden of disease, at Week 192 since LTS6050 randomization. The registry lists the outcome but does not provide the analysis method or a result for it in the registry record for this explanation. Disability progression and MRI measures are not substitutes for the primary safety endpoint; they address separate clinical and statistical questions.
What can planning assumptions tell us?
The registry information describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The intended detectable effect is expressed as a fraction of the observed effect. In general, such calculations illustrate the sample size that might be needed under specified assumptions; they do not describe the trial’s actual power after completion. The record does not report the trial’s own sample-size justification, and an illustration derived from an observed effect is not observed power. Time-to-event planning uses a total event count, whereas other planning outputs are expressed as participants per arm.
The registry does not report the complete primary statistical plan, multiplicity procedure, missing-data method, or interim-analysis plan. Consequently, the named methods for secondary outcomes should not be extended to the primary safety analysis without documentation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes: time to 12 Week Sustained Disability Progression, time to 24 Week Sustained Disability Progression, percentage free of sustained disability progression, annualized MS relapse rate, and MRI change from baseline in abnormal lesion volume at Week 192. It also records six outcome measures and six analyses. When a study evaluates multiple outcomes or time points, the chance of at least one apparently unusual result can increase if no multiplicity strategy is used. In general, multiplicity procedures control or otherwise address this issue. The registry record does not report whether such a procedure was planned or applied, so no adjustment should be assumed.
The record does not describe a missing-data strategy for the primary endpoint or the listed secondary outcomes. It does not say how participants who discontinued, had incomplete follow-up, or lacked a scheduled assessment were handled. For time-to-event analyses, the registry names Kaplan-Meier estimates, but it does not provide details about censoring rules or assumptions. For relapse and MRI outcomes, the model and missing-observation details are not reported in the registry record.
The stated safety population includes participants randomized in LTS6050 who were exposed to investigational medicinal product, regardless of the amount of treatment administered, and says the safety analysis was conducted as treatment received. This defines the population for safety reporting, but it does not answer how missing event information was managed. The primary endpoint is defined over a period ending up to 28 days after last dose, while the record does not state whether follow-up completeness differed by sequence.
These omissions limit assessment of robustness. Without the analysis plan and missing-data details, the reader cannot determine whether the reported summaries reflect all intended observations, how sensitivity analyses were handled, or whether conclusions were adjusted for the set of outcomes examined.
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 |
|---|---|---|---|
| Placebo/Teriflunomide 7 mg | 32 | 129 | 24.8% |
| Teriflunomide 7 mg/7 mg | 71 | 254 | 28.0% |
| Placebo/Teriflunomide 14 mg | 23 | 107 | 21.5% |
| Teriflunomide 14 mg/14 mg | 62 | 250 | 24.8% |
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 |
|---|---|
| Placebo/Teriflunomide 7 mg | 107 of 129 |
| Teriflunomide 7 mg/7 mg | 195 of 254 |
| Placebo/Teriflunomide 14 mg | 95 of 107 |
| Teriflunomide 14 mg/14 mg | 197 of 250 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo/Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | 4 of 129 | 3 of 254 | 3 of 107 | 6 of 250 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 2 of 129 | 5 of 254 | 0 of 107 | 2 of 250 |
| Urinary tract infection | Infections and infestations | 1 of 129 | 1 of 254 | 0 of 107 | 2 of 250 |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 129 | 0 of 254 | 2 of 107 | 1 of 250 |
| Myocardial infarction | Cardiac disorders | 0 of 129 | 1 of 254 | 0 of 107 | 3 of 250 |
| Venous stenosis | Vascular disorders | 0 of 129 | 3 of 254 | 0 of 107 | 1 of 250 |
| Inguinal hernia | Gastrointestinal disorders | 0 of 129 | 2 of 254 | 0 of 107 | 2 of 250 |
| Fall | Injury, poisoning and procedural complications | 1 of 129 | 2 of 254 | 0 of 107 | 1 of 250 |
| Appendicitis | Infections and infestations | 0 of 129 | 2 of 254 | 0 of 107 | 1 of 250 |
| Pneumonia | Infections and infestations | 0 of 129 | 2 of 254 | 0 of 107 | 1 of 250 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo/Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 34 of 129 | 71 of 254 | 29 of 107 | 81 of 250 |
| Headache | Nervous system disorders | 21 of 129 | 42 of 254 | 18 of 107 | 42 of 250 |
| Influenza | Infections and infestations | 19 of 129 | 39 of 254 | 20 of 107 | 37 of 250 |
| Urinary tract infection | Infections and infestations | 20 of 129 | 31 of 254 | 19 of 107 | 36 of 250 |
| Alanine aminotransferase increased | Investigations | 18 of 129 | 36 of 254 | 18 of 107 | 32 of 250 |
| Back pain | Musculoskeletal and connective tissue disorders | 10 of 129 | 37 of 254 | 16 of 107 | 40 of 250 |
| Fatigue | General disorders | 17 of 129 | 37 of 254 | 17 of 107 | 26 of 250 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 14 of 129 | 27 of 254 | 20 of 107 | 32 of 250 |
| Diarrhoea | Gastrointestinal disorders | 16 of 129 | 24 of 254 | 19 of 107 | 30 of 250 |
| Upper respiratory tract infection | Infections and infestations | 15 of 129 | 29 of 254 | 15 of 107 | 28 of 250 |
Serious events with the highest arm-level rate: alanine aminotransferase increased (3.1%), intervertebral disc protrusion (2.0%), uterine leiomyoma (1.9%), pyelonephritis (1.6%), cardiac arrest (1.6%).
The serious adverse-event counts are 32 among 129 at risk for Placebo/Teriflunomide 7 mg, 71 among 254 for Teriflunomide 7 mg/7 mg, 23 among 107 for Placebo/Teriflunomide 14 mg, and 62 among 250 for Teriflunomide 14 mg/14 mg. The other adverse-event counts are 107 among 129, 195 among 254, 95 among 107, and 197 among 250, respectively. These are counts of affected participants, not counts of all separate events.
Seriousness is defined by outcomes or medical importance, including hospitalization, a life-threatening event, death, persistent or significant disability, congenital anomaly or birth defect, or an event considered medically important. The listed serious-event terms and their frequencies are descriptive. For example, the registry lists Alanine aminotransferase increased at 3.1% and Cardiac arrest at 1.6%. These term frequencies do not demonstrate that treatment caused the events or indicate a comparison between treatment sequences.
The groups represent different histories across EFC6049 and the extension, and the record supplies no comparative confidence intervals or inferential tests for these counts. It also reports no deaths in the group data as a count; the death fields are null. A null entry should not be interpreted as a reported zero. The figures describe the posted safety data, not a causal estimate.
12. What the Result Does, and Does Not, Mean
The registry record documents a long-term extension designed primarily to describe safety and tolerability for two teriflunomide doses. Its primary endpoint concerns the percentage of participants with at least one TEAE during an on-treatment period that extends through 28 days after the last dose. The posted safety data give counts of participants with serious and other adverse events by treatment sequence, and the record lists several serious-event terms with percentages.
Those data can be used to understand what the registry reports for the defined safety population. They do not, on their own, establish whether one dose or sequence has a higher underlying risk than another. The record does not provide a primary endpoint estimate, confidence interval, p-value, adjusted comparison, or detailed analysis method for that comparison. The descriptive counts should not be interpreted as proof of a treatment effect or as proof of no treatment effect.
The sequence labels also reflect prior treatment in EFC6049. Some participants entered the extension after placebo and then received teriflunomide; others continued the same teriflunomide dose. This means that a comparison between sequence groups is not simply a comparison of treatment-naive groups exposed to different doses for the same period. Long follow-up and the event window are relevant context, but group-specific follow-up and handling of incomplete observations are not reported.
The secondary outcomes address disability progression, relapses, and MRI lesion volume. Their presence in the registry does not supply results or establish a relationship between those outcomes and the safety endpoint. In general, each endpoint requires its own definition, analysis, and uncertainty assessment. The registry record does not report the full statistical plan or the multiplicity and missing-data procedures.
Accordingly, the most defensible reading is descriptive: the registry records particular adverse-event counts and term frequencies among participants in the stated safety population. Stronger conclusions about comparative safety, causation, efficacy, or clinical importance require evidence and analysis details not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because it concerns long-term safety rather than a short, isolated treatment period. Longer observation can capture events that may not appear during a shorter study, but it also makes the definition of the at-risk period, follow-up completeness, and treatment exposure especially important. The registry defines the TEAE window and describes the treatment sequences, giving readers a basis for understanding what the safety counts represent.
The extension design also illustrates a common interpretive challenge: treatment groups can carry forward different histories from an earlier study. Here, the labels distinguish participants who moved from placebo to teriflunomide from those who continued teriflunomide. An apparent difference between sequences could reflect several features of those histories, and the record does not provide an inferential analysis that separates them.
The distinction between descriptive safety counts and comparative evidence is central. Counts and percentages can communicate the occurrence of events, while confidence intervals and prespecified comparisons are needed to express uncertainty and support a statistical contrast. The registry lists the primary endpoint and safety population but does not report a primary endpoint result or its comparison method. This makes the boundary between what is documented and what remains uncertain particularly important.
The secondary outcomes further demonstrate that different statistical questions call for different approaches. Time-to-event outcomes, recurrent relapse counts, and MRI changes have distinct data structures. The registry names methods for some secondary outcomes, but the statistical details and results are not reported in the registry record for this explanation. The study therefore serves as a useful example of why endpoint definitions, analysis populations, follow-up, and uncertainty must be considered together when reading a long-term clinical trial record.
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 registry record does not provide the primary endpoint’s group percentages, confidence intervals, p-values, or a stated between-group comparison. As a result, the posted adverse-event counts cannot support a formal conclusion about comparative safety. The record also does not report a full statistical analysis plan, including the primary analysis method, prespecified contrasts, multiplicity handling, or interim-analysis plan.
The treatment groups encode exposure during both EFC6049 and the extension. The record describes the extension treatment received after earlier placebo or teriflunomide, but does not provide enough detail to assess how prior exposure and treatment history were incorporated into any comparative analysis. It does not report group-specific follow-up time, exposure-adjusted event rates, or details of discontinuation and censoring.
Missing-data methods are not reported in the registry record. The registry entries do not describe how incomplete safety follow-up, missing event records, or absent secondary outcome measurements were handled. The serious-event term percentages are listed, but the record does not provide their denominators or a comparative analysis for each term. Death entries are null rather than stated counts, so they cannot be read as reported zero counts.
The registry identifies the safety population and says the analysis was conducted as treatment received. That definition clarifies who was eligible for safety reporting, but it does not replace details about endpoint calculation or analysis. The registry’s enrollment figure should not be treated as the denominator for every safety result, since the posted safety denominators are reported by treatment sequence. Finally, the registry record does not report the trial’s own sample-size justification; planning illustrations based on an observed effect do not establish the study’s actual power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis — NCT00803049.
- Registry record last updated 2017-01-30; status last verified 2016-12.
- Results first posted 2017-01-30.
- 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
NCT00803049 is a completed phase 3, randomized, double-blind, parallel-group extension study sponsored by Sanofi. The registry lists 742 enrolled participants, a start of 2006-10, and primary completion in 2015-12. The study focused primarily on long-term safety and tolerability of teriflunomide in multiple sclerosis with relapses.
The extension describes four treatment sequences: placebo followed by teriflunomide 7 mg, continued teriflunomide 7 mg, placebo followed by teriflunomide 14 mg, and continued teriflunomide 14 mg. The primary endpoint is the percentage of participants with TEAEs during the stated on-treatment period. The posted safety results include serious and other adverse-event counts by sequence, but the registry record does not report the primary endpoint’s inferential comparison or the full analysis plan.
Secondary outcomes concern sustained disability progression, relapse rate, and MRI lesion volume. Their analysis details, missing-data handling, and multiplicity procedures are not reported in the registry record.