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 A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (NCT02194699), a randomized phase 3 study. The primary outcome is Annualised Asthma Exacerbation Rate (AAER) up to Week 52.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02194699 |
| Phase | Phase 3 |
| Condition | Uncontrolled Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 856 |
| Arms in the primary outcome | 6 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Adults and adolescents with uncontrolled asthma inadequately controlled on inhaled corticosteroid plus long-acting β2-agonist therapy. The primary analysis population was the FAS: randomised patients with the potential to receive 52 weeks of investigational product who received any investigational product, irrespective of protocol adherence or continued participation.
Intervention
Tralokinumab 300 mg every 2 weeks, given by subcutaneous injection.
Comparator
Placebo subcutaneous injection, with the study described as placebo controlled.
Primary question
How did the annualised asthma exacerbation rate through Week 52 compare between tralokinumab and placebo, overall and in the biomarker subgroups?
The primary endpoint counts qualifying asthma exacerbations and expresses the rate in events per year. The registry record reports results for the overall treatment groups and separately for biomarker-positive and biomarker-negative groups. These subgroup estimates are distinct comparisons; the record does not state that the subgroup findings establish that biomarker status modifies treatment effect.
The principal interpretation should focus on the overall comparison, while treating subgroup estimates as additional evidence requiring cautious interpretation. The available registry information does not specify the biomarker definition, nor does it report a formal treatment-by-biomarker interaction result. It therefore does not establish whether the treatment contrast differs reliably between the biomarker categories. The clinical question is about comparative event rates in the study population and follow-up period, not about an individual participant’s outcome or a recommendation for treatment.
3. Trial Design
This was a phase 3, randomised, triple-masked, parallel-group, placebo-controlled study of tralokinumab in adults and adolescents with asthma inadequately controlled on inhaled corticosteroid plus long-acting β2-agonist therapy. The study description gives a 52-week duration. Tralokinumab was administered as a subcutaneous injection, and the placebo group received a placebo subcutaneous injection.
The registry reports enrollment of 856 and a completed status. The listed start date is 2014-10-30, and the primary completion date is 2017-05-10. These are record-level details and do not, by themselves, describe the timing of individual participants’ follow-up or the completeness of endpoint data.
The primary analysis population is described as the FAS. It included randomised patients who had the potential to receive 52 weeks of investigational product and received any investigational product, irrespective of protocol adherence or continued participation. The group sizes appearing with the primary endpoint are not identical across the biomarker strata and overall groups; the registry record does not give a detailed explanation of those differences. The outcome-specific denominators also vary for the secondary measures.
Randomisation and masking are design features intended to limit systematic differences and bias in comparisons, but the registry record does not report the sequence-generation procedure, allocation concealment details, or who was included in the triple-masked description. Further protocol details, including the sample-size justification and complete statistical analysis plan, are not reported in the registry record. The record lists 18 outcome measures, 35 analyses, and 17 posted secondary outcomes. These counts describe the registry record and should not be read as a complete account of every analysis performed.
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: 1696 patients signed informed consent, 1163 entered screening/run-in period, 856 patients were randomised to receive investigational product (IP) and 849 received treatment. The primary population was the biomarker positive population, defined as all patients with baseline fractional exhaled nitric oxide (FeNO) ≥37 parts per billion (ppb).
Randomised
| Stage | Tralo 300 mg Q2W | Placebo |
|---|---|---|
| STARTED | 428 | 428 |
| COMPLETED | 420 | 417 |
| NOT COMPLETED | 8 | 11 |
Reasons for not completing this period:
| Reason | Tralo 300 mg Q2W | Placebo |
|---|---|---|
| Did not receive treatment | 1 | 5 |
| Without potential for 52 weeks of IP | 5 | 5 |
| Duplicate patient | 2 | 1 |
With Potential to Receive 52 Weeks of IP
| Stage | Tralo 300 mg Q2W | Placebo |
|---|---|---|
| STARTED | 420 | 417 |
| COMPLETED | 370 | 365 |
| NOT COMPLETED | 50 | 52 |
Reasons for not completing this period:
| Reason | Tralo 300 mg Q2W | Placebo |
|---|---|---|
| Adverse Event | 4 | 3 |
| Death | 1 | 3 |
| Lost to Follow-up | 5 | 8 |
| Protocol Violation | 2 | 2 |
| Withdrawal by Subject | 14 | 20 |
| Other | 24 | 16 |
Analysis population for the primary outcome, as defined in the registry: The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in 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: All patients in the full analysis set (FAS) with the potential to receive 52 weeks of IP and who received any IP (tralokinumab or placebo) were included in the baseline analysis.
| Characteristic | Unit | Tralo 300 mg Q2W | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 420 | 417 | 837 | |
| Age, Continuous | Years | 47.3 (SD 15.6) | 48.0 (SD 15.5) | 47.6 (SD 15.5) |
| Sex: Female, Male: Female | Participants | 276 | 290 | 566 |
| Sex: Female, Male: Male | Participants | 144 | 127 | 271 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 3 | 6 |
| Race (NIH/OMB): Asian | Participants | 83 | 88 | 171 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 27 | 24 | 51 |
| Race (NIH/OMB): White | Participants | 283 | 281 | 564 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 24 | 21 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Annualised Asthma Exacerbation Rate (AAER) up to Week 52, measured over Baseline (Week 0) up to Week 52.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Events/year |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the annualised asthma exacerbation rate, or AAER, from baseline through Week 52, expressed in events per year. An exacerbation was defined as worsening asthma leading to systemic corticosteroid use for at least 3 days, an emergency room or urgent care visit due to asthma requiring systemic corticosteroids, or an inpatient hospitalisation due to asthma. A single depot-injectable corticosteroid dose was treated as equivalent to a 3-day systemic corticosteroid course. An emergency or urgent care visit was defined as evaluation and treatment for less than 24 hours; an inpatient hospitalisation involved admission or evaluation and treatment in a healthcare facility for at least 24 hours.
The endpoint converts each participant’s observed exacerbation count into an annualised rate using the number of events and follow-up time. This allows follow-up time to be reflected when participants do not all contribute the same observation period. In general, an event rate is useful when the question concerns the frequency of recurrent events over a period rather than only whether a participant experienced any event.
The registry states that the comparative analysis used a negative binomial model and presents rate ratios and rate reductions. The rate ratio compares event rates between groups; a value corresponding to equal rates represents no relative difference. The confidence interval describes uncertainty around the estimated comparison. AAER is a count-based endpoint, so its interpretation differs from a mean change on a continuous scale. It also depends on the registry’s event definition and follow-up handling; the detailed rules for missing endpoint data are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the overall comparison, the registry reports an annualised rate of 0.84 events per year in the tralokinumab group and 0.82 in the placebo group. The sponsor-reported rate ratio is 1.03, with a 95% confidence interval from 0.81 to 1.31. The interval includes the value corresponding to equal rates, so the posted result is compatible with no relative difference as well as with differences in either direction. The estimate alone does not establish a treatment effect.
The biomarker subgroup estimates are less precise. Among biomarker-positive participants, the reported rate ratio is 0.84, with a 95% confidence interval from 0.53 to 1.34. Among biomarker-negative participants, it is 1.13, with a 95% confidence interval from 0.85 to 1.50. Both intervals include the equal-rate value and span effects in different directions. These subgroup results do not establish a reliable difference between biomarker categories. The registry record does not report a formal interaction analysis that would directly test whether the comparative effect varies by biomarker status.
Confidence intervals matter because the point estimate is only one summary of the data. A wide interval signals that the data allow a substantial range of underlying relative effects. The overall interval is consistent with some reduction and some increase in the rate, so the result should not be reduced to the point estimate alone. Likewise, a result that does not distinguish the groups statistically is not proof that the rates are identical.
For the secondary outcomes with posted comparative results, the sponsor reports repeated-measures analyses for lung function, asthma symptom score and asthma quality-of-life score in biomarker subgroups. Their confidence intervals include no difference. The posted means and standard deviations describe the observed outcome summaries, while the sponsor’s adjusted comparisons are the relevant reported analyses for those outcomes. These secondary data provide context but do not override the primary endpoint result.
The registry also gives serious adverse event counts and other adverse event counts. Those are descriptive safety summaries, not estimates of the primary endpoint or proof of causation. Interpretation of safety requires attention to the group denominators, the event definitions, and the lack of detailed timing or attribution information in the registry record. Overall, the posted results give an uncertain estimate for the primary comparison rather than a precise conclusion about relative exacerbation rates.
9. Statistical Methods Explained
The statistical methods below explain how to read the registry results in general. The registry identifies a negative binomial model for the primary endpoint and repeated-measures analyses for the reported continuous secondary comparisons. It does not report the full statistical analysis plan, so details beyond those stated should not be inferred.
Why use a negative binomial model?
AAER is based on counts of recurrent exacerbations, with follow-up time used to express the count as a rate. A simple model for counts may assume that variability is tightly linked to the average count. In general, clinical event counts can be more variable than that assumption allows; this is called over-dispersion. A negative binomial model allows extra variability and is commonly used for count outcomes when that feature is relevant. The registry names this model, but does not report its diagnostics or the specific model covariates.
The rate ratio expresses the estimated relative event rate for one group compared with the other. A ratio below the equal-rate reference indicates a lower estimated rate in the numerator group, while a ratio above it indicates a higher estimated rate. The direction depends on the comparison’s group order. The registry presents a rate reduction as another way of expressing the comparative analysis. Neither form removes uncertainty: the confidence interval and the model-based test should be considered alongside the point estimate.
What does a confidence interval convey?
A confidence interval is a range of values compatible with the observed data under the analysis and its assumptions. In general, it communicates estimation uncertainty; it is not a guarantee that the true value lies within the particular interval. For the primary overall comparison, the reported 95% interval extends from 0.81 to 1.31 and includes the equal-rate reference. That means the posted results do not sharply distinguish a lower rate from equal rates or a higher rate. The interval’s width is important: focusing only on 1.03 would understate the range of effects still compatible with the analysis.
The p-value addresses how unusual the data would be under a specified null hypothesis and model. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The registry reports p-values for its analyses, but interpretation should not be reduced to whether a threshold is crossed. The effect estimate, confidence interval, design, and analysis population all matter.
How should subgroup analyses be read?
The registry gives separate primary endpoint estimates for biomarker-positive and biomarker-negative participants. Such subgroup estimates can help describe whether patterns appear similar across categories, but separate estimates do not by themselves test whether the treatment effects differ. A formal interaction analysis directly addresses that distinction. An interaction result is not reported in the registry record, and the biomarker definition is not reported there either. The subgroup confidence intervals are broad and include the equal-rate reference, so they should be treated as uncertain rather than as definitive evidence of different effects.
What do the repeated-measures analyses represent?
For selected continuous secondary outcomes, the registry reports repeated-measures analyses and least-squares mean differences. In general, repeated-measures methods account for multiple outcome measurements over time and can estimate group contrasts while using information across visits. A least-squares mean is a model-based mean, and its difference is not necessarily identical to subtracting the endpoint summaries displayed for each group. The registry does not report the complete model specification, covariance structure, handling of missing repeated measurements, or covariate adjustments. The sponsor-reported comparisons should therefore be distinguished from simple unadjusted calculations based on posted summary statistics.
The means and standard deviations describe the observed outcome summaries and their spread. A standard deviation describes variation among observations; it is not the same as a confidence interval for the group mean or for the between-group contrast. The registry’s adjusted confidence intervals and p-values come from its reported repeated-measures analysis. The recalculated comparisons based on summary statistics are simple, unadjusted illustrations and can differ from the sponsor’s model-based estimates.
How should planning illustrations be understood?
Sample-size planning illustrations based on an observed effect are not observed power and are not the trial’s original design justification. In general, such illustrations depend on assumptions about the target effect, variability, allocation, significance level, and analysis method. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of the observed effect. They are planning scenarios only; they do not show what the trial was designed to detect. The actual sample-size assumptions and justification are not reported in the registry record.
The primary endpoint uses a count model, whereas the planning illustrations described for continuous outcomes use a normal approximation. These are different frameworks. The planning values should not be interpreted as evidence that the trial was adequately or inadequately powered, nor as a substitute for its prespecified design assumptions. Those assumptions are not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Negative binomial | Rate ratio 0.84 | 0.53 to 1.34 | 0.466 |
| Negative binomial | Rate ratio 1.13 | 0.85 to 1.50 | 0.413 |
| Negative binominal | Rate reduction 15.83 | -33.71 to 47.01 | 0.466 |
| Negative binomial | Rate ratio 1.03 | 0.81 to 1.31 | 0.803 |
| Negative binominal | Rate reduction -3.14 | -31.46 to 19.08 | 0.803 |
The primary endpoint comparison is reported using the sponsor’s negative binomial analysis. The overall rate ratio is 1.03, with a 95% confidence interval from 0.81 to 1.31. The registry also reports the group-specific annualised rates of 0.84 events per year for tralokinumab and 0.82 for placebo. No separate recalculated primary comparison is listed in the posted results, so there is no summary-statistic recalculation to contrast with the sponsor’s primary model estimate.
For selected continuous secondary outcomes, simple unadjusted recalculations from posted means and standard deviations are distinct from the sponsor’s repeated-measures analyses. The sponsor’s reported results are model-based least-squares mean differences with their own confidence intervals and p-values. Differences between those estimates and unadjusted recalculations can arise because the methods, information used, and adjustment differ. The registry does not report enough model detail to identify every source of any difference.
The discrepancy indicator is not flagged. The sponsor’s analyses remain the primary reported inferential results; unadjusted recalculations should be read as supplementary checks rather than replacements. In general, if a discrepancy were flagged, the sponsor’s own analysis would take precedence. The registry record does not provide a full statistical analysis plan that would permit an independent reproduction of the model-based results.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple outcomes and analyses, including the primary endpoint, secondary outcomes, and biomarker subgroup comparisons. Testing multiple hypotheses can increase the chance of at least one apparently significant result even when none of the underlying effects is real. In general, multiplicity is addressed through a prespecified testing hierarchy, adjustment procedures, or a clearly defined distinction between confirmatory and exploratory analyses. The registry record does not report whether such procedures were used, or how the secondary and subgroup analyses were ordered. Accordingly, individual secondary p-values should not be treated as if they were the only test conducted.
The record identifies the FAS population for the primary analysis and describes its inclusion criteria. It does not report detailed missing-data methods for the primary endpoint, including how incomplete follow-up was handled in the model, or the sensitivity analyses used to assess the impact of missing observations. The AAER calculation uses follow-up time, but that definition alone does not explain how all missing or incomplete data were handled.
For continuous secondary outcomes, the registry names repeated-measures analysis but does not report the missing-data assumptions or the specific approach to incomplete visits. In general, repeated-measures models can use available measurements under assumptions about the missingness process; those assumptions cannot be verified from the registry summary alone. Outcome denominators differ, and the record does not provide a full account of the reasons for missing data or whether those reasons differed by group.
The registry record also does not report the complete statistical analysis plan, the sample-size justification, interim analyses, or detailed subgroup-testing plans. Their absence from the record does not establish that they were not performed; it means the available information does not support conclusions about them. These omissions limit independent assessment of prespecification, multiplicity control, and robustness to missing data.
12. 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 |
|---|---|---|---|
| Tralo 300 mg Q2W | 35 | 425 | 8.2% |
| Placebo | 39 | 422 | 9.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tralo 300 mg Q2W | 1 of 425 |
| Placebo | 4 of 422 |
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 |
|---|---|
| Tralo 300 mg Q2W | 159 of 425 |
| Placebo | 152 of 422 |
Most frequent serious adverse event terms
| Event term | Organ system | Tralo 300 mg Q2W | Placebo |
|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | 17 of 425 | 23 of 422 |
| Pneumonia | Infections and infestations | 4 of 425 | 3 of 422 |
| Angina pectoris | Cardiac disorders | 0 of 425 | 1 of 422 |
| Angina unstable | Cardiac disorders | 0 of 425 | 1 of 422 |
| Atrial fibrillation | Cardiac disorders | 1 of 425 | 0 of 422 |
| Cardiac failure | Cardiac disorders | 0 of 425 | 1 of 422 |
| Myocardial infarction | Cardiac disorders | 1 of 425 | 0 of 422 |
| Colitis ulcerative | Gastrointestinal disorders | 0 of 425 | 1 of 422 |
| Constipation | Gastrointestinal disorders | 0 of 425 | 1 of 422 |
| Dyspepsia | Gastrointestinal disorders | 1 of 425 | 0 of 422 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tralo 300 mg Q2W | Placebo |
|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | 50 of 425 | 52 of 422 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 35 of 425 | 47 of 422 |
| Headache | Nervous system disorders | 40 of 425 | 32 of 422 |
| Bronchitis | Infections and infestations | 34 of 425 | 31 of 422 |
| Upper respiratory tract infection | Infections and infestations | 29 of 425 | 31 of 422 |
| Injection site reaction | General disorders | 23 of 425 | 3 of 422 |
Serious events with the highest arm-level rate: asthma (5.5%), pneumonia (0.9%), angina pectoris (0.2%), angina unstable (0.2%), cardiac failure (0.2%).
The registry reports serious adverse events in 35 of 425 participants in the tralokinumab group and 39 of 422 participants in the placebo group. Other adverse events are reported for 159 of 425 and 152 of 422 participants, respectively. The record also lists 1 death in the tralokinumab group and 4 in the placebo group. These are descriptive counts with their group denominators; they are not adjusted comparisons and do not establish that treatment caused or prevented an event.
Asthma is listed among the most frequent serious adverse event terms at 5.5%, followed by pneumonia at 0.9%. Angina pectoris, unstable angina, cardiac failure and ulcerative colitis are each listed at 0.2%. The registry excerpt does not provide detailed event-level timing, participant overlap across terms, or attribution to study treatment, so the listed percentages should not be combined or interpreted as mutually exclusive categories.
Serious adverse events are a safety category and are distinct from the primary endpoint’s specified exacerbation definition. The counts alone do not establish comparative risk, and the registry record does not provide enough detail for a full safety assessment. They should be read as reported summaries, not as treatment recommendations or proof of causality.
13. What the Result Does, and Does Not, Mean
The primary result is an estimate of comparative annualised exacerbation rates through Week 52 in the study population defined by the registry. The overall rate ratio is 1.03, and its 95% confidence interval, 0.81 to 1.31, includes the value corresponding to equal rates. The data therefore leave meaningful uncertainty about the size and direction of any relative difference. They do not establish that the rates are identical, nor do they establish a reduction or increase.
The biomarker subgroup estimates are also uncertain. Their intervals include the equal-rate reference and extend in both directions. Because a formal interaction result is not reported, separate subgroup estimates do not establish that biomarker status identifies a group with a different comparative response. The biomarker definition is also not reported in the registry record.
These findings apply to the trial’s defined population, intervention, comparator, endpoint definition and follow-up. They do not by themselves answer questions about other populations, treatment regimens, durations or outcomes. The registry summary does not provide the full protocol or analysis plan, and details of missing-data handling, multiplicity and model specification are not reported. Those gaps limit how far the posted estimates can be independently assessed.
The secondary outcomes and safety counts add context, but they have their own uncertainty and limitations. They should not be used to replace the primary analysis or to infer causation from descriptive event counts. The results are statistical evidence about the study comparisons, not individual predictions or medical advice.
14. Why This Trial Matters Statistically
This trial illustrates why a rate-based endpoint and its model need to be interpreted together. Asthma exacerbations can recur, and the primary endpoint expresses events relative to follow-up time rather than reducing the outcome to a simple yes-or-no count of participants with any event. The registry’s negative binomial analysis is suited to count-rate data when extra variability is relevant, although the record does not provide model diagnostics or full specification.
The results also demonstrate why point estimates alone are insufficient. The overall estimate is close to equal rates, but the confidence interval spans a range of relative effects. The uncertainty is central to interpretation: a single estimate cannot establish that the underlying rates differ or are identical. Reporting a confidence interval makes that uncertainty visible.
Biomarker subgroup results raise a separate statistical issue. A pattern of different point estimates across groups is not itself a test of treatment-effect modification. The registry does not report an interaction analysis, so the subgroup estimates should not be promoted into a definitive predictive claim. This distinction is important whenever multiple subgroup comparisons are available.
Finally, the record illustrates limits in registry-level reporting. The primary method and analysis population are identified, but important details on multiplicity, missing data, model specification and design justification are not reported. Those details affect how confidently readers can assess robustness and prespecification. Statistical interpretation therefore depends not only on the reported estimate, but also on precision, population definitions, analysis choices and completeness of reporting.
15. 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 registry information. The biomarker definition and the method used to classify participants are not reported in the registry record. Although separate biomarker subgroup results are given, a formal interaction estimate is not reported, so the record does not establish whether comparative effects differ between the categories.
The primary model is identified as negative binomial, but its complete specification is not reported. The record does not state the covariates, offset implementation, model diagnostics, or sensitivity analyses. It also does not provide detailed methods for handling incomplete follow-up or missing primary endpoint information. These omissions constrain independent evaluation of the model-based estimate.
For the continuous secondary outcomes, repeated-measures analysis is reported, but the model structure, covariance assumptions, adjustment variables and missing-data approach are not described. The posted outcome denominators vary, and the registry does not explain all differences. Numerical results and comparisons are not available for every listed secondary outcome in the information described.
The registry does not report the sample-size justification, complete analysis plan, multiplicity procedures, or interim analyses. It is therefore not possible to determine from the record alone which secondary or subgroup analyses were prespecified or how the overall testing strategy was controlled. The planning illustrations are not a substitute for the original design rationale.
Safety summaries are also limited: counts and selected event terms are reported, but detailed timing, attribution and event-level overlap are not. These reporting limitations do not invalidate the posted results, but they narrow the conclusions that can be drawn from the registry record alone.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma — NCT02194699.
- Registry record last updated 2018-05-15; status last verified 2018-04.
- Results first posted 2018-03-21.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT02194699 is a completed phase 3, randomised, triple-masked, parallel-group, placebo-controlled study of tralokinumab in adults and adolescents with inadequately controlled asthma on inhaled corticosteroid plus long-acting β2-agonist therapy. The study description gives a 52-week period, and enrollment is reported as 856.
The primary endpoint was annualised asthma exacerbation rate through Week 52. The overall sponsor-reported rate ratio was 1.03, with a 95% confidence interval from 0.81 to 1.31. The interval includes equal rates, leaving uncertainty about the comparative effect. Biomarker subgroup intervals are also compatible with equal rates, and a formal interaction result is not reported.
The registry reports additional clinical outcomes and descriptive safety counts. Important details about multiplicity, missing-data handling, full model specifications and the trial’s sample-size justification are not reported in the registry record. Those gaps should be considered when interpreting the posted estimates.