The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy (NCT01694966), a randomized phase 3 study. The primary outcome is To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma..

2. Clinical Question

The question is about detection during colonoscopy, not about subsequent cancer outcomes. The endpoint combines histologically proven adenoma or carcinoma into a participant-level indicator: whether a participant had at least one qualifying finding. It therefore does not describe the total number of lesions, the number of lesions per participant, or the proportion of all lesions detected. The record identifies the primary population as FAS but does not explain how that population was defined or which participants were included in each posted outcome denominator.

3. Trial Design

This was a phase 3, randomized, double-masked, parallel-group trial. The registry records enrollment of 1249 and lists colorectal cancer as the condition. It names Cosmo Technologies Ltd as sponsor. The recorded study start was 2013-09, the primary completion was 2016-10, and the status is completed. The registry record does not describe the randomization method, allocation concealment, the masking procedures, or which trial roles were masked.

Three regimens were assigned. Participants in the Methylene Blue MMX® 200mg group took 8 Methylene Blue MMX® tablets orally over a 4hr schedule. The Methylene Blue MMX® 100mg group took 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule. The placebo group took 8 Placebo tablets over a 4hr schedule. The study summary frames the primary question as detection with mucosal contrast enhancement compared with colonoscopy using white light.

The primary outcome analysis lists 485 participants in the 200mg group, 241 in the 100mg group, and 479 in the placebo group. These are the group sizes posted with the outcome and are not necessarily the same as the enrollment figure or the denominators used for safety reporting. The safety record gives different at-risk counts for some groups. The registry record does not explain those differences or provide a participant flow account in the registry record for this analysis.

The primary endpoint is listed for the FAS at +7 days. The meaning and construction of FAS, the handling of participants without an evaluable colonoscopy or histology result, and the timing of endpoint ascertainment beyond the stated timeframe are not reported in the registry record. The design information establishes a randomized, masked comparison, but it does not by itself establish the details of analysis implementation or whether every randomized participant contributed to each outcome.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: FAS

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.

6. Primary Endpoint

The registry lists the primary outcome as To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma., measured over +7 days.

The primary endpoint is the percentage of participants with at least one histologically proven adenoma or carcinoma. It is identified as the Adenoma Detection Rate and is assessed in the FAS at +7 days. Each participant contributes to the endpoint as having or not having at least one qualifying finding; it is not a count of all adenomas or carcinomas and does not measure the number of lesions per colonoscopy.

General: A participant-level binary endpoint can be useful when the clinical question concerns whether an examination finds at least one condition of interest. Reporting the percentage makes the outcome comparable across groups of different sizes without treating each lesion as an independent participant. Histological confirmation specifies that the qualifying finding must be proven by tissue examination, rather than counted solely from visual appearance. The registry record does not provide more detail on the histology process or the rules for classifying findings.

The endpoint reflects detection in the context of screening or surveillance colonoscopy. It does not, by itself, measure later cancer incidence, mortality, the number of lesions missed, or the clinical consequences of detecting a lesion. Nor does a group percentage indicate that every participant in that group had the same outcome. The record does not report other posted outcome measures, so the posted primary endpoint is the available basis for interpreting the trial’s detection comparison.

7. Results Posted in the Registry

• Methylene Blue MMX® 200mg: 56.3% (273/485) versus 47.8% (229/479) on control; risk difference 8.5 percentage points (95% CI 2.2 to 14.8), risk ratio 1.18 (1.04–1.33); unadjusted two-proportion z-test p = 0.008.
• Methylene Blue MMX® 100mg: 51.5% (124/241) versus 47.8% (229/479) on control; risk difference 3.6 percentage points (95% CI -4.1 to 11.4), risk ratio 1.08 (0.92–1.26); unadjusted two-proportion z-test p = 0.356.

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a binary percentage endpoint: the percentage of participants with an event. For this trial, the event is having at least one histologically proven adenoma or carcinoma. The outcome is therefore based on whether each participant meets the endpoint definition, rather than the number of findings per participant. The posted arm results are 56.3% for Methylene Blue MMX® 200mg, 51.5% for Methylene Blue MMX® 100mg, and 47.8% for placebo.

What does a risk difference represent?

General: A risk difference compares the event probabilities in two groups by subtracting one group’s probability from the other’s. It is an absolute measure: it describes the difference in percentage of participants meeting the endpoint, not a relative change. A positive value for the active-group-minus-placebo comparison indicates a higher observed event probability in the active group; a negative value indicates a lower observed probability. The posted comparisons are expressed as risk differences and are recalculated from the posted summary statistics. Their exact decimal estimates are not repeated; the comparison display reports the estimates and confidence intervals.

The direction of the risk difference should be read together with the group percentages and the confidence interval. For the 200mg comparison, the interval lies above zero. For the 100mg comparison, it includes zero. These features describe the unadjusted calculations and do not by themselves establish that a treatment effect is clinically important or that the groups are equivalent. No clinical threshold for an important difference is reported in the registry record.

How should the confidence interval be read?

General: A confidence interval is an uncertainty range calculated from the observed data using a specified method. In repeated use under the method’s assumptions, intervals constructed in this way would cover the underlying parameter at the stated confidence level at the method’s long-run rate. A narrower interval indicates more precision for that estimate; a wider interval indicates more uncertainty. A confidence interval is not a range containing a fixed proportion of individual participants, and it is not a guarantee that the true effect lies within its endpoints.

The posted risk-difference intervals concern the difference between group probabilities, not the individual group percentages alone. An interval entirely on one side of zero is inconsistent with zero difference at the corresponding two-sided confidence level under the calculation method. An interval that crosses zero does not rule out a difference; it indicates that the interval includes zero as well as values on either side. The registry record does not state a confidence level or detail the interval calculation method in the registry record, so the interval should be read as posted rather than attributed to an unreported model.

What do the p-values convey?

The unadjusted p-values are 0.008 for 200mg versus placebo and 0.356 for 100mg versus placebo. General: A p-value is calculated under a null hypothesis, commonly that the groups have no difference, and a statistical model. It describes how compatible the observed data are with that null and model, not the probability that the null is correct. A smaller p-value can indicate that the data are less compatible with the null under the calculation assumptions, but it does not measure the size, importance, or certainty of an effect.

These p-values are described as unadjusted because the posted values do not account for multiplicity. The registry record does not provide an adjustment method, a significance threshold for the trial’s own analysis, or a full statistical analysis plan. The planning illustration separately specifies a two-sided significance level of 0.05, but that stated planning assumption should not be mistaken for confirmation of the original trial’s analysis rule. The record does not report that original design assumption.

What does the randomization contribute?

General: Random assignment is intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics at baseline. It supports a causal comparison when allocation is implemented as planned, outcome ascertainment is appropriate, and analysis preserves the randomized comparison. Double masking can reduce the influence of expectations on care, conduct, or assessment, depending on who is masked and how masking is maintained. The registry record identifies randomization and double masking but does not describe the procedures or the masked roles.

The posted group sizes for the primary endpoint are not equal: 485 for 200mg, 241 for 100mg, and 479 for placebo. The sample-size illustration’s equal-allocation assumption belongs to its planning calculations, not to the observed trial groups. The registry record does not give the allocation ratio intended by the protocol or explain the arm-size pattern. It also does not report baseline characteristics in the registry record for this analysis, so balance cannot be assessed from these outcome summaries alone.

What is not specified?

The registry record lists one outcome measure and no posted secondary outcome measures. It records no analyses in the analysis count, while outcome comparisons are available as recalculated unadjusted statistics. The original trial statistical plan, any interim analyses, the prespecified analysis population rules, missing-data procedures, and adjustment for covariates or multiplicity are not reported in the registry record. These omissions limit assessment of how closely the displayed calculations reflect the trial’s original analysis. They do not change the arithmetic meaning of the posted group percentages, but they matter when evaluating the analysis as a whole.

General: Over-dispersion is relevant when data vary more than a model assumes, which can make standard errors too small and intervals too narrow if it is ignored. It is a concern for certain count or clustered outcomes, such as multiple findings within a participant or correlated observations within sites. The primary endpoint is a participant-level binary outcome, and no over-dispersion parameter is reported. The registry record gives no basis for claiming that over-dispersion was assessed or was a concern in the original analysis.

10. Confidence Intervals and Precision

The primary comparison’s recalculated, unadjusted confidence interval for the risk difference lies entirely above zero. In contrast, the interval for Methylene Blue MMX® 100mg versus placebo includes zero. This describes how the intervals relate to no difference under the calculation method. The registry record does not report the confidence level or detailed interval method in the registry record for this analysis, so the intervals should not be given a stronger interpretation than their stated comparison supports.

General: Precision concerns how tightly an estimate is determined by the data and method. A confidence interval communicates uncertainty about a group comparison, while the point estimate gives one value from that calculation. An interval can include both potentially meaningful positive and negative values and still be statistically compatible with zero. Conversely, an interval excluding zero does not establish that the estimated difference is large enough to matter clinically. Assessing clinical importance would require a context-specific threshold, which is not reported in the registry record.

The sample sizes posted for the primary outcome are 485 for the 200mg group, 241 for the 100mg group, and 479 for placebo. The comparisons consequently do not have identical data support. The displayed group percentages are rounded to one decimal place, while the recalculated comparisons use the posted summary statistics. No confidence intervals are posted for the individual arm percentages in the registry record for this analysis.

Precision also depends on matters not conveyed by the interval alone, including the endpoint definition, missing outcome data, analysis population, and potential bias in outcome assessment. The registry record identifies the FAS but does not define it or report missing-data handling. It also does not supply subgroup or longer-term outcome estimates. The intervals therefore describe uncertainty for the specified unadjusted comparisons, not every uncertainty relevant to interpreting the trial.

11. 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, not total events. They are illustrations based on the observed effect and are not the trial’s original design calculations. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect. The original trial’s own sample-size assumptions are not reported in the registry record.

The 80% power column gives the number of participants per arm in the planning illustration for a design with an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one. The 90% power column gives the corresponding per-arm planning number for a 90% chance. These are prospective design concepts, not probabilities that the observed result is correct. For example, planning for 75% of the observed effect requires more participants per arm than planning for the full observed effect. Planning for 50% requires still more, because smaller effects are harder to distinguish from random variation.

The display includes separate planning scenarios for 200mg versus placebo and 100mg versus placebo. The per-arm figures differ between comparisons because the observed effects used as the basis for the illustrations differ. For the 200mg comparison, the listed per-arm requirements for 80% power are 544 when planning for 100% of the observed effect, 969 for 75%, and 2,182 for 50%. The corresponding figures for 90% power are 728, 1,297, and 2,920. These are planning illustrations, not observed participant counts or evidence about the original trial’s design.

These figures do not represent observed power. Observed power calculated from an observed effect largely restates the result’s uncertainty and is not a useful substitute for interpreting the estimate and confidence interval. The illustration also assumes equal allocation, whereas the posted outcome group sizes are unequal. Its figures are therefore best read as hypothetical planning guidance under the stated assumptions, not as an evaluation of whether the completed trial was adequately designed.

12. 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 = 0.478; treatment proportion p₁ = 0.563; average p̄ = 0.520.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7065 = 1.3847.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.7040 = 0.5925.
4. n = (1.3847 + 0.5925)² / (0.0848)² = 543.6, rounded up to 544 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 <- 0.478079331941545                          # control proportion
p1 <- 0.562886597938144                          # 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(1694966)
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 = 544 (80% power), 728 (90% power)
 75% of observed effect: n per arm = 969 (80% power), 1,297 (90% power)
 50% of observed effect: n per arm = 2,182 (80% power), 2,920 (90% power)
power.prop.test: 543.6 
Simulated power at n = 544 per arm: 0.797 (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.

13. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure: the primary Adenoma Detection Rate endpoint. It lists no posted secondary outcome measures and records no analyses in the analysis count. Nevertheless, two active-group comparisons with placebo appear in the posted results: Methylene Blue MMX® 200mg versus placebo and Methylene Blue MMX® 100mg versus placebo. Their p-values are unadjusted.

General: Multiplicity arises when several hypotheses or outcomes are tested. If each test is interpreted on its own without adjustment, the chance of at least one apparently unusual result across a collection of tests can increase. Whether adjustment is appropriate depends on the trial’s planned questions and testing strategy. The registry record does not report a multiplicity procedure, a hierarchy of comparisons, or whether the 100mg comparison was considered confirmatory or exploratory. The unadjusted p-values should therefore be understood as individual comparisons, not as values adjusted across the set of comparisons.

The primary population is labelled FAS. The registry record does not define that population or state whether the analysis followed intention-to-treat principles, which participants were excluded, or how participants with missing endpoint data were handled. It also does not report the amount or pattern of missing outcome data. These details are important because exclusions or missing results can affect which participants contribute to each group percentage and comparison.

The registry record does not report the original statistical analysis plan, covariate-adjusted models, interim analyses, or a method for handling missing data. It also does not explain whether the posted calculations reproduce the sponsor’s primary analysis. The comparison statistics are unadjusted recalculations from posted summary statistics, and the record marks no discrepancy. They can be interpreted as straightforward group comparisons, while conclusions about the trial’s full prespecified analysis remain limited by the absent details.

Because there are no posted secondary outcome results, there is no basis in this record for drawing conclusions about outcomes beyond the primary detection measure. Missing analysis details should not be replaced by assumptions about the protocol or the trial team’s decisions; those details are not reported in the registry record.

14. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: haematochezia (0.4%), viral bronchitis (0.2%).

The registry reports serious adverse event counts and at-risk denominators by safety group. The serious adverse event figures are 1 among 485 at risk in the Methylene Blue MMX® 200mg group, 1 among 241 at risk in the Methylene Blue MMX® 100mg group, and 0 among 479 at risk in the placebo group. The registry also lists haematochezia at 0.4% and viral bronchitis at 0.2% among the top serious adverse event terms. Death counts are not reported in the registry record.

These are descriptive safety counts, not adjusted comparisons. The registry record does not supply a statistical comparison of serious adverse events or details about event adjudication, follow-up, or the relationship of each event to study treatment. The safety denominators differ from some of the primary outcome denominators: the 200mg safety group lists 488 at risk for other adverse events, while its serious-event denominator is 485. The corresponding 100mg counts are 241 and 241, and the placebo counts are 479 and 479. The record does not explain the denominator difference for the 200mg group.

Other adverse events are reported as affecting 234 participants in the 200mg group, 102 in the 100mg group, and 7 in the placebo group, using the at-risk counts recorded for other adverse events. These counts do not identify severity or establish causation. A small number of serious events in these data should not be interpreted as proof that serious harms cannot occur; the registry record does not provide a complete assessment of safety beyond the posted adverse event information.

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

The posted primary result describes the percentage of participants with at least one histologically proven adenoma or carcinoma during the trial’s specified colonoscopy assessment. That percentage was 56.3% in the Methylene Blue MMX® 200mg group and 47.8% in the placebo group. The recalculated unadjusted comparison has a confidence interval above zero and an unadjusted p-value of 0.008. These findings concern the observed participant-level detection endpoint in the trial population and timeframe.

The 100mg group had a posted rate of 51.5%, compared with 47.8% for placebo. Its recalculated unadjusted confidence interval includes zero, and its unadjusted p-value is 0.356. This result does not establish equivalence or prove that there is no difference. It indicates that the posted unadjusted comparison does not distinguish the observed difference from zero using the interval and p-value shown.

General: Statistical evidence and clinical importance are related but distinct. A result can be statistically distinguishable from zero without crossing a threshold that would be considered important for practice, and a result that is not statistically distinguishable from zero can still be compatible with effects that matter. The registry record does not report a threshold for clinical importance, so the results should not be labelled clinically meaningful or unimportant on the basis of these statistics alone.

The endpoint does not answer whether the intervention changes long-term cancer outcomes, reduces mortality, or improves outcomes after a lesion is found. It also does not report the number of lesions detected, the fraction of all lesions detected, or effects in participant subgroups. The registry record does not provide posted secondary outcome results. Accordingly, the results should not be generalized beyond the stated detection measure, trial groups, and study context without additional evidence.

The safety record gives descriptive serious adverse event counts, but it does not provide a causal analysis or a full account of all potential harms. Neither the efficacy comparison nor the adverse event counts establish that a regimen works or does not work for an individual. The interpretation is limited to what the registry reports and to the unadjusted calculations based on its outcome summaries.

16. Why This Trial Matters Statistically

This trial illustrates how a binary detection endpoint translates a colonoscopy result into a participant-level percentage. The endpoint is not a lesion count: each participant is classified according to whether at least one histologically proven adenoma or carcinoma was found. That distinction matters because the resulting percentage answers a different question from the number of lesions detected or the proportion of lesions detected.

The primary comparison also shows why an effect estimate and its uncertainty should be read together. The observed group percentages differ, and the recalculated unadjusted interval for 200mg versus placebo lies above zero. The 100mg comparison has a different pattern: its interval includes zero. These are not interchangeable conclusions, and neither interval alone establishes clinical importance. Reporting both the scale of the endpoint and the precision of the comparison gives a more informative account than relying on a p-value alone.

The three-arm design makes the comparison structure important. The primary question concerns 200mg versus placebo, while the record also includes 100mg versus placebo. Without a reported multiplicity plan, the unadjusted p-values should not be treated as if they necessarily account for all comparisons. Likewise, an additional dose comparison does not automatically have the same interpretive status as the primary comparison.

Finally, the registry contains a distinction between outcome and safety denominators, and it does not describe the original analysis plan, missing-data procedures, or the definition of FAS. Those omissions demonstrate why numerical results need context about populations, analysis choices, and reporting. The posted calculations support a focused interpretation of the available endpoint; they do not resolve questions that the registry record leaves unreported.

17. 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 interpretation is limited by the information recorded about the analysis. Although the primary population is labelled FAS, its definition and participant inclusion rules are not reported in the registry record. Missing endpoint data, exclusions, and the method used to handle them are also not reported. The posted outcome denominators therefore cannot be fully reconciled with the enrollment figure from the available information.

The comparison statistics are unadjusted recalculations from posted summary statistics. The registry record does not provide the original statistical analysis plan, any covariate-adjusted estimates, multiplicity handling, interim analysis information, or a detailed interval method. It also does not say whether the sponsor used other analyses for its primary conclusion. The registry marks no discrepancy between the summaries and recalculations, but the calculations do not replace a full analysis report.

There are no posted secondary outcome measures or secondary outcome results in the record. The primary endpoint is a participant-level measure and does not reveal lesion counts, lesion-level sensitivity, or longer-term outcomes. No subgroup estimates are reported in the registry record for this analysis. The study’s outcome definition is described, but further details about histological assessment and endpoint adjudication are not reported.

The record identifies a randomized, double-masked design but does not explain randomization procedures, allocation concealment, masking roles, or maintenance of masking. Safety reporting is descriptive; the registry does not report a comparative safety analysis, death counts, or detailed event attribution. In addition, the 200mg safety denominator for other adverse events differs from its serious adverse event denominator, without an explanation. These limits do not negate the recorded findings, but they constrain how broadly they can be interpreted.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy — NCT01694966.
• Registry record last updated 2017-11-06; status last verified 2017-10.
• Results first posted 2017-11-06.
• 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.

21. Record Summary

NCT01694966 is a completed phase 3 randomized, double-masked, parallel-group trial sponsored by Cosmo Technologies Ltd. It studied oral Methylene Blue MMX® regimens and placebo in subjects undergoing screening or surveillance colonoscopy. The recorded enrollment is 1249; the study start was 2013-09 and primary completion was 2016-10.

The primary endpoint was the percentage of FAS participants with at least one histologically proven adenoma or carcinoma at +7 days. The posted rates were 56.3% for Methylene Blue MMX® 200mg, 51.5% for Methylene Blue MMX® 100mg, and 47.8% for placebo. Recalculated unadjusted comparisons show a confidence interval above zero for 200mg versus placebo and an interval including zero for 100mg versus placebo.

The registry record does not report secondary outcome measures, define FAS, or describe the original statistical plan and missing-data handling. Safety results include serious adverse event counts by group, but no comparative safety analysis or death counts are reported.