A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile (NCT02702388), a randomized phase 2 study. The primary outcome is Objective Response Rate (ORR) as of Week 24 (ORR24wk).

2. Clinical Question

3. Trial Design

This was a multicenter, randomized, double-blind, parallel-group phase 2 trial. It compared two active starting doses of lenvatinib: 18 mg once daily and 24 mg once daily. The study record describes dose reductions as permitted in both groups, with arm-specific dose levels. The record also lists matching placebo, consistent with the stated double-blind design, but the complete description of blinding procedures is not reported in the registry record.

The study enrolled 241 participants. The primary-outcome results use 75 participants in the 24 mg group and 77 in the 18 mg group. The primary analysis population is described as the full analysis set, including all participants randomly assigned to treatment. The distinction between total enrollment and the denominators reported for this endpoint is not explained in the registry record.

The trial status is completed. The registry record gives a start date of 2017-06-08 and a primary completion date of 2019-12-12. It describes the study as a postmarketing requirement to the US Food and Drug Administration. The original sample-size justification, planned power, allocation ratio, and other design assumptions are not reported in the registry record. Although the posted results include an analysis designated as non-inferiority, the protocol details needed to evaluate the design of that analysis are 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.

Before assignment: A total of 241 participants were screened and enrolled of which 89 participants were screen failures, and 152 participants were randomized and treated.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: FAS included all participants randomly assigned to treatment.

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: Full analysis set (FAS) included all participants randomly assigned to treatment.

6. Primary Endpoint

The registry lists the primary outcome as Objective Response Rate (ORR) as of Week 24 (ORR24wk), measured over From the date of randomization up to Week 24.

The primary endpoint was objective response rate as of Week 24. It was defined as the percentage of participants whose best overall response by that time was complete response or partial response, assessed using RECIST 1.1. A complete response required disappearance of target lesions, with pathological lymph nodes reduced to less than 10 mm in short axis. A partial response required at least a 30% decrease in the sum of target-lesion diameters relative to baseline.

Objective response is a binary outcome at the participant level: each participant either met the complete-or-partial-response definition by the specified time point or did not. Reporting the percentage makes the result interpretable as the fraction of the analysis group meeting the response criteria. The Week 24 limit also fixes the period over which response is counted, rather than treating responses at any later time as part of this primary measure.

The registry record states that the primary outcome was measured from randomization up to Week 24 and that the full analysis set included all randomly assigned participants. How participants with missing or unevaluable assessments were handled is not reported in the registry record. The endpoint records radiographic response under specified criteria; it does not, on its own, summarize response duration, survival, symptoms, or overall safety.

7. Results Posted in the Registry

• Lenvatinib 18 mg: 40.3% (31/77) versus 57.3% (43/75) on control; risk difference -17.1 percentage points (95% CI -32.7 to -1.4), risk ratio 0.70 (0.50–0.98); unadjusted two-proportion z-test p = 0.035.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Model Predicted Apparent Total Clearance (CL/F) Following Oral Dosing of Lenvatinib

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Lenvatinib 18 mg: mean 6.24 versus 6.41 on control; difference -0.17 (95% CI -0.72 to 0.39), standardized effect d = -0.08; z-test p = 0.559.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lenvatinib 18 mg and the control. The interval gives the range of effects that remain compatible with the data.

Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Lenvatinib 18 mg: mean 3,370 versus 3,747 on control; difference -377.00 (95% CI -1,402 to 648.24), standardized effect d = -0.18; z-test p = 0.471.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lenvatinib 18 mg and the control. The interval gives the range of effects that remain compatible with the data.

The registry record lists secondary outcomes spanning progression-free survival, progression-free survival after the next line of treatment, adverse events, treatment discontinuation due to adverse events, dose reductions, and model-predicted pharmacokinetic measures. These outcomes address different aspects of disease course, tolerability, treatment exposure, and treatment modification. They therefore provide context for the primary response endpoint, but they are not interchangeable with it.

Among the detailed secondary results, the model-predicted apparent total clearance and area under the plasma concentration-time curve have unadjusted comparisons with confidence intervals that include no mean difference. This pattern does not provide a clear statistical separation between starting-dose groups for those model-predicted measures. The results are estimates with uncertainty, and they do not independently establish similarity or equivalence. Numerical results and full analysis details for the other listed secondary outcomes are not reported in the registry record.

Secondary analyses generally carry less weight than the primary comparison when many outcomes are examined. Repeated testing increases the chance that some results may appear notable by chance, particularly when no multiplicity adjustment is reported. The registry record does not report a multiplicity plan or adjusted secondary analyses. The secondary findings should therefore be viewed as supportive or exploratory context rather than as independent confirmation of the primary result. They also cannot supply the missing non-inferiority margin or settle whether the lower starting dose met the trial’s stated combined efficacy and safety aim.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Progression-free Survival (PFS)
• PFS After Next Line of Treatment (PFS2)
• Number of Participants With TEAE and Serious Adverse Events (SAEs)
• Time to Treatment Discontinuation Due to an Adverse Event (AE)
• Number of Dose Reductions
• Time to First Dose Reduction
• Model Predicted Apparent Total Clearance (CL/F) Following Oral Dosing of Lenvatinib
• Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib

9. Statistical Interpretation

10. Statistical Methods Explained

What does the response rate represent?

Objective response rate is a proportion: it counts participants meeting the response definition and relates that count to the analysis group. In this trial, response means complete or partial response under RECIST 1.1 by Week 24. The reported percentages are estimates of the response proportions in the two randomized groups, not guarantees about the response of any individual participant. The full analysis set is described as all participants randomly assigned to treatment, though the endpoint denominators are smaller than total enrollment and the handling of missing assessments is not reported in the registry record.

What does the risk difference add?

A risk difference subtracts one group’s outcome proportion from the other group’s proportion. The recalculated estimate uses the 18 mg group relative to the 24 mg group, so a negative estimate denotes a smaller observed response proportion in the 18 mg group. Its confidence interval describes the range of differences compatible with the posted counts under the calculation’s assumptions. Because this is a simple unadjusted recalculation, it does not incorporate covariate adjustment or any additional features of the sponsor’s statistical analysis. The sponsor’s own analysis takes precedence only when the registry record identifies a discrepancy; no discrepancy is identified for this result.

How do the odds ratio and risk difference differ?

An odds ratio compares the odds of response between groups, while a risk difference compares the response proportions directly. Both express a contrast, but their numerical scales are not interchangeable. The registry record reports the sponsor’s result as an odds ratio and separately supports a simple recalculation on the risk-difference scale. The sponsor’s odds ratio is labeled as a non-inferiority analysis. A non-inferiority interpretation depends on a prespecified margin and its relation to the estimate and confidence interval. The margin and the statistical method are not reported in the registry record, so the reported odds ratio cannot by itself verify the non-inferiority criterion.

What do confidence intervals and p-values convey?

A confidence interval conveys the precision of an estimate under the statistical method used: narrower intervals indicate less sampling uncertainty, while wider intervals indicate more. It is not a range that guarantees the true value lies inside it. A p-value measures how unusual the observed data, or data more extreme, would be under a specified null hypothesis and the calculation’s assumptions. It does not measure the probability that the null hypothesis is true, nor does it measure clinical importance. The recalculated p-value is unadjusted. The sponsor’s posted non-inferiority analysis has no p-value reported in the registry record.

What is not described about the analysis?

The registry record gives the primary endpoint definition, population description, group results, and a sponsor-reported odds ratio. It does not report the test or model used for that odds ratio, the non-inferiority margin, missing-data methods, covariate adjustments, or a full prespecified statistical analysis plan. It also does not report whether there were interim analyses or how decisions about them were made. Those details should not be inferred from the outcome estimates. The recalculated risk difference and its interval are unadjusted comparisons from the posted group-level counts, rather than a replacement for a more detailed sponsor analysis.

11. Confidence Intervals and Precision

The primary outcome estimates have meaningful uncertainty. In the 24 mg group, the response estimate is 57.3%, with a 95% confidence interval from 46.1% to 68.5%. In the 18 mg group, the estimate is 40.3%, with a 95% confidence interval from 29.3% to 51.2%. The intervals overlap, but overlap or non-overlap of separate group intervals is not the formal test of the between-group contrast. The direct recalculated risk-difference interval is the more relevant interval for that contrast.

For the 18 mg group relative to the 24 mg group, the recalculated risk difference is -0.171, with a 95% confidence interval from -0.327 to -0.014. This interval is entirely below zero, indicating that the unadjusted comparison is compatible with a lower response proportion in the 18 mg group and does not include no difference. Its width also reflects substantial uncertainty about the size of that difference. The estimate should not be read as a precise measure of the effect that would recur in another study.

The sponsor’s odds ratio estimate is 0.50, with a 95% confidence interval from 0.26 to 0.96. The interval is on the odds-ratio scale and should not be interpreted as a risk-difference interval. Its upper limit is near the null value for an odds ratio, while the registry record does not state the non-inferiority margin that would be required for the sponsor’s stated analysis. Confidence intervals quantify sampling uncertainty under a method; they do not address missing-data bias, selective reporting, or other design limitations.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm because this is a binary outcome, not total event counts. They are illustrations computed from the observed effect, not the original trial design justification. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The trial’s original design assumptions are not reported in the registry record.

For planning at 100% of the observed effect, the illustration gives 134 participants per arm for 80% power and 179 participants per arm for 90% power. At 75% of the observed effect, the figures are 239 participants per arm for 80% power and 319 participants per arm for 90% power. At 50% of the observed effect, they are 536 participants per arm for 80% power and 717 participants per arm for 90% power. The 80% and 90% columns describe the probability of detecting the specified effect under the planning assumptions if that effect were the true one and the analysis conditions held.

Smaller effects require more participants per arm to achieve the same target power, which is why the illustrative sample sizes rise as the effect fraction decreases. These figures are not observed power and do not show whether the completed trial had a particular probability of finding its result. They are planning illustrations based on the observed effect, which itself is uncertain.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.573; treatment proportion p₁ = 0.403; average p̄ = 0.488.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7069 = 1.3855.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6965 = 0.5862.
4. n = (1.3855 + 0.5862)² / (-0.1707)² = 133.4, rounded up to 134 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.573333333333333                          # control proportion
p1 <- 0.402597402597403                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2702388)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 134 (80% power), 179 (90% power)
 75% of observed effect: n per arm = 239 (80% power), 319 (90% power)
 50% of observed effect: n per arm = 536 (80% power), 717 (90% power)
power.prop.test: 133.4 
Simulated power at n = 134 per arm: 0.798 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s posted analysis reports an odds ratio of 0.50 with a 95% confidence interval from 0.26 to 0.96. It is designated as a non-inferiority analysis. No p-value, method, or non-inferiority margin is reported in the registry record. The odds ratio is a different effect measure from the unadjusted recalculated risk difference, so their numerical values should not be compared as if they were on the same scale.

The recalculation uses the posted response counts to estimate a risk difference for the 18 mg group relative to the 24 mg group. It gives -0.171, with a 95% confidence interval from -0.327 to -0.014 and p = 0.035. This is a simple unadjusted calculation rather than a reconstruction of the sponsor’s full statistical method. The registry record does not identify a discrepancy between the sponsor analysis and the recalculation, so the recalculation should be read as a complementary contrast, not as a correction to the sponsor result.

The sponsor’s non-inferiority label does not by itself establish that non-inferiority was demonstrated. That assessment depends on the prespecified margin and analysis details, which are not reported in the registry record. The available estimates describe the reported association between assigned starting dose and response; the full basis for the sponsor’s inferential conclusion cannot be assessed from the posted analysis details alone.

15. Multiplicity, Missing Data and Analysis Populations

The registry record identifies a primary Week 24 objective response outcome and lists numerous secondary outcomes. It reports 33 outcome measures and one analysis in the record summary. The statistical plan for prioritizing the primary and secondary analyses, and any procedure for controlling the family-wise chance of false-positive findings across multiple tests, is not reported in the registry record. The recalculated p-value is explicitly unadjusted, and the detailed secondary comparisons are also unadjusted.

Multiplicity matters because examining several outcomes or contrasts creates more opportunities for a result to appear unusual by chance. A prespecified adjustment can change how individual p-values and confidence intervals are interpreted. Without a reported plan, the posted unadjusted results should not be read as if they were protected from the consequences of multiple testing. The registry record also does not report whether interim analyses took place or whether the inferential plan changed over time.

The primary population is described as all participants randomly assigned to treatment. The posted endpoint denominators are 75 and 77, while total enrollment is 241. The registry record does not explain the difference between total enrollment and the analyzed denominators for this outcome. It does not report the number of missing or unevaluable Week 24 assessments, the method used to handle them, or whether any participants were excluded from the full analysis set despite its definition. Therefore, the possible effect of missing outcome information on the estimates cannot be assessed.

Other important analysis details are also absent: the statistical method for the sponsor’s odds ratio, any covariate adjustment, the non-inferiority margin, and the complete prespecified analysis plan. These omissions limit independent assessment of whether the posted analyses follow the planned inferential strategy. They do not invalidate the reported numbers, but they constrain the strength and scope of conclusions that can be drawn from them.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: malignant neoplasm progression (4.0%), pneumonia (3.9%), sepsis (3.9%), malignant pleural effusion (3.9%), post procedural complication (2.7%).

The registry record reports serious adverse events in 26 of 75 participants in the 24 mg group and 35 of 77 participants in the 18 mg group. Other adverse events are reported in 75 of 75 participants in the 24 mg group and 76 of 77 participants in the 18 mg group. Deaths are reported for 11 participants in the 24 mg group and 19 participants in the 18 mg group. These are counts among the stated at-risk group sizes, not estimates of a causal effect.

The registry record also lists serious-event terms and percentages, including malignant neoplasm progression, pneumonia, sepsis, malignant pleural effusion, post procedural complication, and pneumothorax. The displayed terms do not establish that an event was caused by study treatment. The record does not provide a comparative statistical analysis for these safety counts, and the basis for the listed term percentages is not specified in the available details.

Differences in raw counts should be interpreted cautiously: counts alone do not account for exposure time, event timing, severity, recurrence, or the reasons for death. The registry record does not report enough detail to determine treatment attribution for deaths or events. These figures describe the posted safety experience; they do not, by themselves, establish that one starting dose has a better safety profile.

17. What the Result Does, and Does Not, Mean

The primary outcome describes the proportion of participants meeting a radiographic response definition by Week 24. The posted group estimates are higher for the 24 mg starting-dose group than for the 18 mg starting-dose group. The unadjusted risk-difference estimate is negative when expressed as 18 mg relative to 24 mg, and its 95% confidence interval excludes zero. This is evidence of a difference in the observed response proportions under that unadjusted calculation, with substantial uncertainty about the magnitude.

The sponsor reports an odds ratio and labels the analysis non-inferiority, but the registry record does not report the margin required to evaluate that claim. The estimates therefore do not, on their own, establish whether the lower starting dose met the prespecified non-inferiority criterion. Nor do the primary results answer the full question of whether a lower starting dose offers a better safety profile. The safety counts need context and a comparative analysis to support that assessment.

Objective response is only one outcome. It does not summarize progression-free survival, survival, treatment discontinuation, quality of life, or the complete safety experience. Some of these outcomes are listed as secondary measures, but their full results and analysis details are not reported in the registry record. The response estimates should not be generalized beyond the population, endpoint definition, and follow-up period described in the trial record.

These findings are statistical descriptions of the posted results, not medical advice. They do not determine which dose is appropriate for an individual, and they should not be interpreted as proving that either dose is effective, ineffective, safe, or unsafe. Interpretation is limited by the unreported non-inferiority margin, analysis methods, missing-data handling, and multiplicity plan.

18. Why This Trial Matters Statistically

This trial poses a statistical question that cannot be answered by comparing response percentages alone. The design compares two active starting doses and frames the lower dose around both efficacy comparability and safety. For a non-inferiority question, the size of an acceptable loss in efficacy must be defined in advance. The registry record labels the sponsor analysis as non-inferiority but does not report the margin, making it difficult to evaluate whether the analysis supports that specific claim.

The comparison also illustrates why effect measures matter. The sponsor reports an odds ratio, while the simple recalculation expresses the contrast as a risk difference. Both can describe the relationship between groups, but each answers the contrast on a distinct scale. Presenting the estimate with its confidence interval helps distinguish the observed direction from the uncertainty around its magnitude.

Precision is central to interpreting the results. The response estimates are based on the endpoint group sizes posted in the registry record, and their intervals leave uncertainty about the true response proportions and contrast. Planning illustrations based on the observed effect show how required sample size depends on the effect a future study is designed to detect. Those illustrations are not a retrospective measure of the completed trial’s power.

Finally, the stated goal includes safety as well as response. Safety counts are important descriptions but need appropriate denominators, event timing, attribution, and comparative methods for stronger inference. The record’s missing details about analysis planning and missing outcomes demonstrate why transparent statistical reporting is necessary to assess a clinical trial’s claims.

19. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The registry record does not report the non-inferiority margin, the statistical method used for the sponsor’s odds ratio, or a complete prespecified analysis plan. Without the margin, the non-inferiority claim cannot be independently assessed from the reported estimate and interval. The record also does not report how missing or unevaluable Week 24 assessments were handled, or explain why the primary endpoint denominators are smaller than total enrollment.

The primary comparison’s recalculated risk difference is an unadjusted analysis of posted group-level counts. It cannot account for participant-level covariates or features of a sponsor analysis that are not described. The p-value is unadjusted, and the record does not report a multiplicity strategy despite listing many outcome measures. This limits how strongly the result can be interpreted in the context of other analyses.

Safety outcomes are reported as counts, but the registry record does not provide the comparative statistical analysis, event timing, detailed attribution, or exposure-adjusted summaries needed to assess differences fully. The listed serious-event terms and deaths should not be interpreted as treatment-caused events based on these figures alone.

Finally, the trial was described as phase 2 and the primary result concerns a specific response definition and time point. The registry record does not provide full results for all listed secondary outcomes, and the posted information does not resolve questions about durability of response or broader clinical outcomes. These limitations narrow what can be concluded from the recorded estimates.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile — NCT02702388.
• Registry record last updated 2021-11-24; status last verified 2020-12.
• Results first posted 2021-01-11.
• 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.

23. Record Summary

NCT02702388 is a completed, randomized, double-blind, parallel-group phase 2 trial comparing lenvatinib starting doses of 18 mg and 24 mg once daily in radioiodine-refractory differentiated thyroid cancer. The registry record lists 241 enrolled participants and identifies Week 24 objective response rate as the primary outcome. The posted response estimates are 40.3% for the 18 mg group and 57.3% for the 24 mg group.

The sponsor reports an odds ratio of 0.50 with a 95% confidence interval from 0.26 to 0.96 and designates the analysis as non-inferiority. The registry record does not report the non-inferiority margin or key analysis details. The unadjusted recalculated risk difference is -0.171, with a 95% confidence interval from -0.327 to -0.014. Safety counts are reported, but they do not alone establish comparative safety. Missing-data methods and multiplicity handling are not reported in the registry record.