A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema (NCT03866473), a randomized na study. The primary outcome is Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months.

2. Clinical Question

The trial’s central comparison is a difference in average change, not a comparison of each participant’s outcome with a fixed threshold. A negative mean difference for photobiomodulation relative to placebo indicates a lower average change in that arm; it does not by itself establish how individual eyes changed or what caused those changes.

The registry describes the study as evaluating photobiomodulation compared with sham in eyes with central-involved diabetic macular edema and good vision. Its primary endpoint is an OCT measurement, while other listed outcomes include retinal volume, visual acuity, center-involved edema status, alternative treatment, and a later CST change. The record does not report a prespecified clinically important difference for the primary endpoint, so the magnitude should be read as a measured difference rather than judged against a threshold absent from the record.

3. Trial Design

This was a randomized, quadruple-masked, parallel-group pilot study. The registry lists the phase as NA and enrollment as 135. The sponsor was Jaeb Center for Health Research. The study began on 2019-04-10, had primary completion on 2020-09-04, and is listed as completed.

The two groups were Photobiomodulation (PBM) and Placebo. The PBM device was described as emitting light at a 670nm wavelength; the placebo device was described as broad spectrum. Both descriptions specify use twice a day for 90 seconds through 4 months. The registry descriptions also indicate that at the 4-month visit, participants who had not already received alternative treatment for diabetic macular edema would return their original device and receive the alternative treatment group device. The wording of those descriptions is incomplete in the registry record, so further details of that arrangement are not reported.

The primary endpoint summaries include 68 eyes in the PBM group and 66 in the placebo group. Those endpoint counts are not an explanation of the trial’s original allocation or enrollment accounting. The registry record does not report the original sample-size justification or other design assumptions, and no reported formal analysis results are listed. The treatment groups and results should therefore be interpreted using the posted outcome descriptions and summaries, rather than assumptions about an analysis plan that is not reported.

The randomized design creates a basis for comparing the assigned groups, while masking is intended to limit knowledge of assignment during trial conduct. The registry record does not identify which four roles were masked. The parallel model indicates separate groups rather than a within-participant comparison of assigned treatments during the initial study period.

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: Visit completion at 4 months was prespecified as completion of any study visit from 12 to 24 weeks but due to the COVID19 pandemic, the window was extended to 32 weeks and participants in Phase 2 could also discontinue device use.

Phase 1

Reasons for not completing this period:

Phase 2

Reasons for not completing this period:

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 Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 4 Months, measured over Baseline to 4 months.

The primary endpoint is change in optical coherence tomography central subfield thickness from baseline to 4 months, measured in microns. OCT produces images of the retina; central subfield thickness is a quantitative measure of thickness in the central region. In a trial about diabetic macular edema, this measure gives a structural outcome that can be compared between assigned groups.

The endpoint is expressed as a mean change for each group. The PBM group had a mean change of 13 microns, with a standard deviation of 53, among 68 eyes. The placebo group had a mean change of 15 microns, with a standard deviation of 57, among 66 eyes. The comparison is the difference between those group means, with PBM minus placebo defined by the posted comparison.

OCT thickness is one way to characterize retinal structure; it is not itself a measure of every aspect of vision or participant experience. The registry lists visual acuity and other outcomes separately. No clinically important threshold for a CST change is reported in the registry record, so the endpoint’s numerical difference should not be treated as a demonstrated benefit or harm without such context.

7. Results Posted in the Registry

• Photobiomodulation (PBM): mean 13.00 versus 15.00 on control; difference -2.00 (95% CI -20.65 to 16.65), standardized effect d = -0.04; z-test p = 0.834.

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.

Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months

• 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:
  • Photobiomodulation (PBM): mean 0.12 versus 0.10 on control; difference 0.02 (95% CI -0.14 to 0.18), standardized effect d = 0.05; z-test p = 0.801.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Photobiomodulation (PBM) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Visual Acuity From Baseline to 4 Months

• 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:
  • Photobiomodulation (PBM): mean -0.20 versus -0.60 on control; difference 0.40 (95% CI -1.31 to 2.11), standardized effect d = 0.08; z-test p = 0.648.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Photobiomodulation (PBM) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months

• 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:
  • Phase 2 Photobiomodulation (PBM): mean -1.00 versus -2.00 on control; difference 1.00 (95% CI -14.04 to 16.04), standardized effect d = 0.02; z-test p = 0.896.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Phase 2 Photobiomodulation (PBM) and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes spanning retinal structure, visual acuity, center-involved edema status, alternative DME treatment, and CST change from 4 to 8 months. Numerical group summaries and unadjusted comparisons are available for retinal volume change, visual acuity change, and the later CST change. The registry record does not provide numerical results for every listed secondary outcome.

Across the available continuous secondary comparisons, the estimated differences are small relative to their reported uncertainty, and the unadjusted confidence intervals include zero. This broad pattern is consistent with the primary comparison in the limited sense that none of these posted comparisons sharply distinguishes the groups. It does not prove that all outcomes have no effect, or that different outcome measures should be expected to move together.

Secondary outcomes can provide context, but they do not replace the primary endpoint. Their interpretation is weaker when many outcomes or comparisons are considered without a reported plan for controlling multiplicity. In general, examining many outcomes increases the chance that at least one result will look notable by chance. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting secondary outcomes. The unadjusted secondary results should therefore be treated as exploratory rather than as independent confirmation of a treatment effect.

The listed outcomes also address different questions and time periods. A structural OCT measure, a visual acuity score, and a count of eyes meeting a threshold do not have interchangeable meanings. Because the record does not report full results for every secondary outcome, the overall pattern is necessarily limited to the continuous comparisons with posted numeric summaries. The secondary results add context to the primary result but do not resolve its uncertainty.

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

• Mean Change in Retinal Volume on Optical Coherence Tomography From Baseline to 4 Months
• Number of Eyes With Center-involved Diabetic Macular Edema on Optical Coherence Tomography at 4 Months
• Number of Eyes Receiving Alternative Treatment for Diabetic Macular Edema
• Change in Visual Acuity From Baseline to 4 Months
• Change in Optical Coherence Tomography Central Subfield Thickness From 4 to 8 Months

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean change represent?

A mean change is the average of the changes measured for the eyes included in the relevant group summary. It condenses the group’s outcomes to one number, but does not show the spread of individual measurements or their distribution. The standard deviations reported with the primary endpoint describe variability among the measurements; they are not uncertainty limits for the group mean.

The comparison is the PBM mean minus the placebo mean. Its estimate of -2.0 microns means that the PBM group’s average change was lower than the placebo group’s average change by that amount, using the direction defined in the posted results. This is a contrast between group averages. It is not a count of eyes that improved or worsened.

What is a confidence interval?

A confidence interval expresses uncertainty around an estimated difference using a method with a stated long-run coverage property. In general, a wider interval indicates less precision than a narrower one. For this endpoint, the reported interval runs from -20.65 to 16.65 microns. Because it includes zero, the data are compatible with no average difference under the interval method, as well as with differences on either side of zero. The interval is not a range containing every individual eye’s outcome.

What does a p-value say?

In general, a p-value describes how unusual data at least as incompatible with a specified null model would be if that model were correct. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The posted unadjusted p-value for the primary comparison is 0.834. The registry record does not report a formal analysis plan or a threshold used by the study investigators, so this calculated value should not be presented as a reported sponsor analysis.

How do missing outcomes affect the analysis?

The primary endpoint description states that multiple imputation was used for missing CST and retinal volume changes, with m = 100. In general, multiple imputation fills in missing values repeatedly using a model based on observed information, and combines the resulting estimates to reflect uncertainty from missingness. The described imputation models included treatment group, baseline values, changes from baseline at monthly interim visits up to the primary outcome visit, and the randomization stratification factor of recent or planned intravitreous treatment in the non-study eye.

The same description says that imputation was not performed for center-involved DME because its thresholds are gender- and machine-specific. It also says descriptive OCT statistics included only eyes that completed the 4-month visit. For eyes receiving alternate DME treatment before 4 months, the last OCT measurements before that treatment were used instead of 4-month measurements; the record lists N=3 for PBM and N=1 for placebo. The record’s description of intent-to-treat analyses and its description of the descriptive summaries concern different aspects of the results and should not be conflated.

Why can variability matter?

General statistical explanation: when measurements vary considerably within groups, a difference between group means can be estimated less precisely, unless the study has enough information to overcome that variability. The primary standard deviations, 53 and 57 microns, are large relative to the estimated difference of -2.0 microns. This context helps explain why the confidence interval is broad; it does not establish why the variability occurred.

Over-dispersion is a general concern when data vary more than an analysis model expects. For a continuous outcome such as CST, the registry record does not identify an over-dispersion model or report a diagnostic assessment. It would therefore be speculative to claim that over-dispersion was present or that a particular method was used to address it. The description does report that OCT CST change was truncated to the mean ± 3 SD, but the associated registry text is incomplete; further interpretation of that procedure is not reported.

What is the role of the registry summaries?

The means, standard deviations, confidence interval, and unadjusted comparison support a descriptive statistical reading of the posted result. The registry record lists no reported formal analyses. As a result, the calculations should be distinguished from investigator-reported adjusted analyses, and they do not reveal unreported model choices, diagnostic checks, or sensitivity analyses.

11. Confidence Intervals and Precision

The primary comparison has a 95% confidence interval from -20.65 to 16.65 microns around the estimated mean difference of -2.0 microns. The interval crosses zero, so the posted result does not isolate a difference in one direction. Its span also indicates substantial uncertainty about the size and direction of the underlying average difference.

A confidence interval is about precision in estimating a group contrast, not the range of outcomes for individual eyes. In general, a narrower interval means that estimates compatible with the data are more tightly concentrated; a wider interval permits a broader range. Here, the estimate is close to zero, but the interval is not narrow enough to support a conclusion that the true difference must be close to zero. Nor does it establish that an important difference exists.

The interval should be interpreted alongside the outcome’s units and the absence of a reported clinically important difference. Without a prespecified threshold, statistical uncertainty can be described, but the registry record does not supply a basis for deciding what size of CST difference would be clinically meaningful.

The unadjusted p-value is 0.834. It should not replace the interval: the p-value summarizes evidence relative to a null model, while the interval displays a range of values compatible with the estimation procedure. Neither number establishes equivalence, and neither resolves limitations from missing data or unreported analysis details.

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 sample-size illustrations are planning examples based on the observed effect, not the trial’s original design calculation. For this continuous endpoint, the figures mean participants per arm, not total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The scenarios consider detecting 100%, 75%, or 50% of the observed effect.

The 80% power column describes the number of participants per arm that a hypothetical study would need, under those assumptions, to have an 80% chance of detecting the chosen effect if that effect were the true one. The 90% power column gives the corresponding planning target for a 90% chance. These are design probabilities under the assumptions, not guarantees for a future study. This is not observed power.

The primary endpoint estimates are based on a small observed difference relative to the group variability. Planning estimates based on a small effect can therefore be large. Within the displayed scenarios, planning for 75% or 50% of the observed effect means targeting a smaller difference than planning for the full observed effect; smaller effects require more participants to detect with the same power and assumptions.

The plotted curve represents the same kind of planning relationship: as the target effect becomes smaller, the required sample size rises. It does not add information about what the study originally planned, and it should not be interpreted as evidence that the trial had adequate or inadequate power for its actual design. The original sample-size assumptions are not reported in the registry record.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.000; pooled standard deviation σ = 55.006.
2. n = 2 × (1.96 + 0.842)² × 55.006² / -2.000² = 11,874.0, rounded up to 11,875 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
delta <- -2                      # observed difference in means
sigma <- 55.0060602721797                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3866473)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 11,875 (80% power), 15,896 (90% power)
 75% of observed effect: n per arm = 21,110 (80% power), 28,260 (90% power)
 50% of observed effect: n per arm = 47,497 (80% power), 63,584 (90% power)
power.t.test: 11875 
Simulated power at n = 11,875 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures and five posted secondary outcomes, but it does not report a multiplicity strategy for interpreting the collection of outcomes. No formal analyses are listed as reported. The unadjusted comparisons should consequently be read outcome by outcome, with caution about treating any one result as confirmatory when several outcomes are under consideration.

In general, multiplicity arises when researchers assess many outcomes, contrasts, or time points. Without an adjustment or a prespecified hierarchy, the chance of at least one apparently unusual result can increase. The registry record does not report whether the investigators used an adjustment outside the posted record, so no claim about such a procedure can be made.

The primary endpoint description reports that analyses followed the intent-to-treat principle and that multiple imputation with m = 100 was used for missing CST and retinal volume changes. The models included treatment group, baseline values, changes from baseline at monthly interim visits up to the primary outcome visit, and the randomization stratification factor concerning recent or planned intravitreous treatment in the non-study eye. In general, multiple imputation relies on its model and assumptions about missingness; the registry does not report sensitivity analyses that would show how results might change under other assumptions.

For descriptive OCT statistics, only eyes completing the 4-month visit were included. The description says that the last OCT measurements before alternative DME treatment were substituted for the 4-month measurements for eyes receiving such treatment before that visit, listing N=3 for PBM and N=1 for placebo. Imputation was not performed for center-involved DME because the thresholds are gender- and machine-specific. The record does not report details needed to assess missingness for every outcome or the handling of all other departures from follow-up.

The original sample-size justification, interim analysis plan, and fuller statistical analysis plan are not reported in the registry record. These omissions limit assessment of how the reported summaries relate to prespecified design choices.

15. 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 0.01% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: covid-19 (3.3%), congestive heart failure (1.6%), chest pressure (1.6%), liver failure (1.6%), chronic kidney disease (1.6%).

The registry reports serious adverse events by phase and intervention group, with both the number at risk and the number affected. In Phase 1, the PBM group had 5 serious adverse events among 69 at risk, and the placebo group had 9 among 66 at risk. In Phase 2, the PBM group had 4 among 61 at risk, and the placebo group had 1 among 62 at risk. The record also lists 1 death in Phase 1 PBM, none in Phase 1 placebo, none in Phase 2 PBM, and 2 in Phase 2 placebo.

These are descriptive counts, not adjusted comparisons or evidence that an intervention caused an event. The registry also lists COVID-19 at 3.3% as a top serious-event term, and congestive heart failure, chest pressure, liver failure, chronic kidney disease, and appendicitis at 1.6% each. Those terms and percentages do not establish attribution to the study device. The record does not report a statistical comparison of safety between groups.

The phase-specific groups should be kept distinct when reading the figures. The record does not explain in detail how the safety phases relate to all participants’ exposure or event timing, so the counts should not be combined or interpreted as a single treatment-period estimate.

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

The posted primary result estimates a small difference in mean OCT CST change between the randomized groups over baseline to 4 months. The point estimate is -2.0 microns for PBM minus placebo, with a 95% confidence interval from -20.65 to 16.65 microns. These data do not provide a precise estimate of the direction or size of the underlying difference.

This result does not establish that the two interventions are equivalent. Equivalence requires an appropriate design and a prespecified margin for judging whether differences are acceptably small; no such margin is reported in the registry record. A p-value of 0.834 is not proof that there is no effect. Conversely, the observed mean difference alone does not demonstrate a clinically meaningful effect.

The endpoint is an OCT structural measurement, not a complete account of vision or of all aspects of diabetic macular edema. The registry lists other outcomes, but it does not report numerical results for every listed secondary measure. The available secondary comparisons do not remove the primary result’s uncertainty, and unadjusted secondary findings deserve particular caution when multiple outcomes are assessed.

The registry describes a pilot study, and its sample-size planning assumptions from the original design are not reported. Its posted summaries can inform the magnitude and uncertainty of this comparison, but they do not establish what a larger or differently designed study would find. No treatment recommendation follows from these results. The reasonable statistical conclusion is limited: the estimated average difference is near zero, while the interval remains broad enough to include differences in either direction.

17. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the difference between a point estimate and the precision of an estimate. The primary mean difference is close to zero, but its confidence interval spans values on both sides of zero. Reporting only the point estimate would obscure that uncertainty; treating the p-value as a definitive answer would also overstate what the data establish.

The study also illustrates how outcome variability affects interpretation. The standard deviations are much larger than the estimated difference, and the resulting interval is broad. This is a reminder that a small observed contrast and an imprecise estimate are not the same as proof of no difference.

Its registry description makes missing-data choices visible: it distinguishes descriptive summaries from intent-to-treat analyses, describes multiple imputation for CST and retinal volume, and specifies how pre-treatment OCT measurements were used for certain eyes. These details help readers ask whether the analyzed summaries match the question of interest, while the absence of a fuller analysis plan limits independent appraisal.

Finally, the planning illustrations show why sample-size interpretation depends on the effect a future study aims to detect. They use the observed effect and stated generic assumptions, not the study’s original design rationale. Keeping planning scenarios separate from observed results avoids mistaking a hypothetical design calculation for evidence about the trial’s achieved power or its conclusions.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves important design and analysis details unreported. It does not give the original sample-size justification, a full statistical analysis plan, interim analysis details, or a multiplicity strategy. The four masking roles are not identified. These gaps prevent a complete assessment of how the posted comparisons align with the investigators’ prespecified methods.

The primary outcome has a broad confidence interval, and the registry gives no clinically important difference for CST. This limits conclusions about practical importance. The study is described as a pilot, and the record does not report a population description beyond central-involved DME and good vision. Further eligibility and participant characteristics are not available in the endpoint description.

Missing outcomes and alternative treatment also complicate interpretation. The record describes imputation for CST and retinal volume, but not for center-involved DME, and the imputation approach depends on the stated model. The descriptive OCT summaries include only eyes completing the 4-month visit, with last measurements before alternative treatment used for specified eyes. The registry does not report sensitivity analyses to assess the impact of these choices.

Some arm descriptions are incomplete, including the device exchange wording at the 4-month visit. Numeric results are not reported for every listed secondary outcome, and safety data are organized by phase without a full account of event timing or attribution. These limitations support a cautious reading of the posted summaries rather than broad conclusions beyond the measured comparisons.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema — NCT03866473.
• Registry record last updated 2022-09-19; status last verified 2022-09.
• Results first posted 2022-06-10.
• 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.

22. Record Summary

NCT03866473 is a completed randomized, quadruple-masked, parallel pilot study of photobiomodulation compared with a sham device for diabetic macular edema. The registry lists enrollment as 135 and identifies Jaeb Center for Health Research as the sponsor. The primary outcome is mean change in OCT central subfield thickness from baseline to 4 months.

The posted primary comparison is -2.0 microns for PBM minus placebo, with a 95% confidence interval from -20.65 to 16.65 microns and an unadjusted p-value of 0.834. The interval includes differences in either direction and does not establish equivalence. The record describes multiple imputation for missing CST and retinal volume changes, but does not report the original sample-size justification or a multiplicity plan.

The registry lists secondary outcomes and phase-specific adverse-event counts, but not every listed secondary outcome has numerical results. Interpretation is limited to the outcomes and analysis details reported in the registry record.