IV Ketorolac on Platelet Function Post-Cesarean Delivery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for IV Ketorolac on Platelet Function Post-Cesarean Delivery (NCT03805607), a randomized phase 4 study. The primary outcome is Platelet Aggregometry.

2. Clinical Question

This is a focused measurement question, not a direct assessment of clinical bleeding or pain outcomes. The registry record lists postpartum hemorrhage, postoperative blood loss, and postoperative pain among the conditions associated with the study, but the posted primary endpoint is a laboratory measure of platelet function. The record also lists thromboelastography parameters as secondary outcomes. Those outcomes provide additional laboratory measurements, but do not change what the primary endpoint measures. The posted results therefore describe the laboratory outcomes at the stated measurement time; they do not by themselves establish what happened to clinical outcomes.

3. Trial Design

The registry record describes a Phase 4, randomized, quadruple-masked, parallel-group trial sponsored by Beth Israel Deaconess Medical Center. Enrollment is listed as 40. The record lists the study start as 2021-01-18, primary completion as 2022-02-03, and status as completed. These registry entries describe the trial's administrative design and status; they do not give a complete protocol or statistical analysis plan.

Participants were assigned to ketorolac or placebo. The ketorolac arm received 30 mg in 1 ml, and the placebo arm received 1 ml of normal saline. The primary outcome was platelet aggregometry, measured as percentage of light transmission and described as percentage inhibition of platelet aggregation. The stated timeframe was 15 minutes after dosing. The endpoint results list a mean and standard deviation in each arm, along with a mean difference and confidence interval for the comparison.

Thromboelastography measurements are listed as secondary outcomes. The registry record names reaction time (R), angle (Alpha), kinetics (K-time), and maximum amplitude (MA). Numerical results are posted for R, Alpha, and K-time; numerical MA results are not reported in the registry record. The record lists five outcome measures overall and reports no analyses in its analyses listing.

The endpoint result counts differ from the enrollment figure: the primary results list 14 participants for placebo and 17 for ketorolac. The adverse-event section, separately, lists 20 at-risk participants in each arm. The registry record does not explain the relationship among these counts, and it does not report the analysis populations or reasons for differences. Original sample-size assumptions, eligibility details, and the detailed conduct of masking 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.

Overall Study

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.

Population: Results describe protocol compliant analysis of the participants, including only those who had completed the study protocol completely.

6. Primary Endpoint

The registry lists the primary outcome as Platelet Aggregometry, measured over 15 minutes after dosing of placebo or ketorolac.

The primary endpoint is platelet aggregometry, reported as percentage of light transmission. The registry description explains that the outcome is determined from the percentage inhibition of platelet aggregation by comparing values before and after dosing. It also defines a higher inhibition value as greater inhibition of aggregation and, in this measurement context, a greater drug effect on platelet function. The recorded timeframe is 15 minutes after dosing of placebo or ketorolac.

In general, platelet aggregometry is a laboratory measure of how platelets aggregate under the test conditions. A pre-dose and post-dose comparison is intended to capture a change following exposure; comparing the groups can then describe whether the recorded changes differ. The registry record does not provide further detail about the assay procedure, the specific aggregation stimulus, or how the pre-dose and post-dose values were combined beyond its endpoint description.

This laboratory endpoint is relevant to the study's stated aim of evaluating platelet function after ketorolac exposure. It is not itself a measure of bleeding, transfusion, postpartum hemorrhage, or another clinical event. Those clinical outcomes should not be inferred from a difference in an assay measure alone. The posted results are therefore best read as a short-term comparison in a platelet-function measure at the stated time, alongside the separately reported thromboelastography outcomes.

7. Results Posted in the Registry

• Ketorolac: mean 59.10 versus 65.40 on control; difference -6.30 (95% CI -12.41 to -0.19), standardized effect d = -0.67; z-test p = 0.043.

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.

Thromboelastogram Parameters Including Reaction Time (R)

• 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:
  • Ketorolac: mean 5.30 versus 4.50 on control; difference 0.80 (95% CI -0.76 to 2.36), standardized effect d = 0.33; z-test p = 0.314.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Ketorolac and the control. The interval gives the range of effects that remain compatible with the data.

Thromboelastogram Parameters Including Angle (Alpha)

• 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:
  • Ketorolac: mean 77.10 versus 76.50 on control; difference 0.60 (95% CI -0.42 to 1.62), standardized effect d = 0.40; z-test p = 0.251.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Ketorolac and the control. The interval gives the range of effects that remain compatible with the data.

Thromboelastogram Parameters Including Kinetics (K-time)

• 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:
  • Ketorolac: mean 0.93 versus 0.94 on control; difference -0.01 (95% CI -0.11 to 0.10), standardized effect d = -0.05; z-test p = 0.893.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Ketorolac and the control. The interval gives the range of effects that remain compatible with the data.

The secondary results cover three posted thromboelastography measures: reaction time (R), angle (Alpha), and kinetics (K-time). The mean differences point in different directions, and their confidence intervals all include zero. This overall pattern does not provide a uniform separation between the groups across the measures. Maximum amplitude (MA) is also listed as a secondary outcome, but numerical results are not reported in the registry record.

These findings should be considered alongside, rather than as replacements for, the primary platelet aggregometry result. The primary endpoint is a distinct laboratory measure, and the thromboelastography results assess different parameters. A pattern in one measure need not be reproduced in another. The posted results therefore offer a set of related laboratory observations, not multiple interchangeable readings of one outcome.

The secondary p-values are unadjusted. In general, when several outcomes are examined, the chance of at least one apparently unusual result can increase if each is assessed without accounting for the others. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a prespecified interpretation of the secondary outcomes. This makes isolated secondary p-values less persuasive as confirmatory evidence than results from a clearly specified primary analysis.

The record reports no analyses in its analyses listing and does not describe missing-data or analysis-population procedures. The absence of posted numerical MA results also means the full named set of secondary outcomes cannot be evaluated from the results section. These reporting limits matter when describing the overall secondary pattern: the available measures can be summarized, but the record does not establish why a measure is absent or whether additional analyses were performed outside the posted results.

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

• Thromboelastogram Parameters Including Reaction Time (R)
• Thromboelastogram Parameters Including Angle (Alpha)
• Thromboelastogram Parameters Including Kinetics (K-time)
• Thromboelastogram Parameters Including Maximum Amplitude (MA)

9. Statistical Interpretation

10. Statistical Methods Explained

The posted continuous outcomes are summarized by group means and standard deviations. A mean describes the arithmetic average of the measured values in a group; a standard deviation describes how spread out the values are around that average. In general, a mean difference compares the group averages, with the sign depending on the order used for the comparison. Here, the primary comparison is ketorolac versus placebo, and its reported difference is -6.3. The registry gives the group means as 59.1 for ketorolac and 65.4 for placebo.

In general, a confidence interval gives a range of values reasonably compatible with the observed data under the method used to construct it. Its width reflects precision: a narrower interval indicates more precise estimation, while a wider interval indicates less precision. The primary interval is reported as -12.41 to -0.192. The registry record does not state the specific method used to construct this interval, so the interval can be described as posted but its calculation procedure cannot be independently assessed from the record alone.

The p-value is another summary of uncertainty, but it answers a different question from the confidence interval. In general, a p-value measures how unusual data at least as incompatible with a specified null model would be if that model were true, subject to the analysis assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of a difference. The primary p-value is reported as unadjusted. The registry record does not give a full analysis plan or identify whether any other inferential procedures were used.

The standard deviations in the primary groups are 2.7 for placebo and 12.5 for ketorolac. In general, unequal spreads can matter because some statistical procedures assume similar variability between groups. The registry record does not describe the method used for the mean comparison, whether it accounted for unequal variances, or whether model adjustments were made. The reported pooled standard deviation and standardized effect measure are available in the posted calculation material, but they do not establish which method the trial investigators used. No analyses are listed in the registry's analysis section.

General statistical context: over-dispersion means that observed variability is greater than a model or procedure expects. When the analysis assumes less variability than is present, standard errors may be too small and intervals too narrow. This trial reports continuous outcomes and standard deviations; the registry record does not identify an over-dispersion assessment or suggest that a model involving over-dispersion was used. The relevant general point is that variation and model assumptions affect precision, and these assumptions should be made explicit when the analysis method is reported.

The record describes randomization and masking, which are design features intended in general to reduce systematic differences and influence in treatment assignment or outcome assessment. It does not report the sequence-generation method, concealment details, or how masking was implemented. Thus, the stated design labels can be reported, but the practical protections and any departures from them are not assessable from the registry record.

The outcome is described as a change based on pre-drug and post-drug platelet aggregometry values, while the posted table reports means by arm and a mean difference. The record does not clarify whether the displayed group values represent post-dose measurements, change scores, or another calculated form of the outcome beyond the written endpoint description. It also does not report baseline values, a baseline-adjusted model, missing-data handling, or a primary analysis population. These omissions matter because different choices can affect an estimate and its uncertainty.

The posted planning illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They show the participants per arm associated with 80% or 90% power for a stated fraction of the observed effect. In general, power is the chance that a specified procedure would meet its decision criterion if a particular effect and model assumptions held. These illustrations are not evidence about the power achieved in this completed trial. The original trial sample-size calculation and its assumptions are not reported in the registry record.

The record lists one primary endpoint and several secondary outcomes, but does not report a multiplicity adjustment. In general, evaluating several outcomes creates more opportunities for chance findings if each is tested separately. Adjustment or a prespecified hierarchy can address this issue, but the registry record does not say whether either was used. As a result, the secondary p-values are best understood as unadjusted descriptive inferential results, with limited grounds for treating them as confirmatory.

11. Confidence Intervals and Precision

The primary mean difference is reported as -6.3, with a 95% confidence interval from -12.41 to -0.192. This interval is entirely below zero, but it covers a range of possible mean differences rather than identifying one exact value. The estimate is therefore more informative than a direction alone, while still leaving uncertainty about the magnitude. The posted unadjusted p-value is 0.043; it does not remove that uncertainty or describe the clinical importance of the endpoint difference.

In general, confidence intervals reflect both the observed data and the statistical method used. Their precision depends on factors such as sample size, variability, and model assumptions. The primary endpoint table lists 14 participants in the placebo group and 17 in the ketorolac group, and the group standard deviations are 2.7 and 12.5. The difference in reported spreads is relevant context when considering precision. The registry record does not identify the interval calculation method or state whether the analysis allowed for unequal variability.

The secondary confidence intervals are less conclusive about direction: each posted interval spans zero. This means the reported estimates do not distinguish clearly between positive and negative differences at the level represented by those intervals. It is not proof that the groups are identical. The MA outcome has no numerical results in the registry record, so its precision cannot be assessed from the posted results.

Precision is also limited by uncertainty about which participants contributed to each analysis. Enrollment is listed as 40, while the primary endpoint table reports arm counts of 14 and 17. The record does not explain this difference or report missing-data handling. Without that information, readers cannot determine from the registry record whether the endpoint results represent all randomized participants, a subset, or another analysis population. The intervals should be read as the uncertainty reported for the posted analysis, not as a resolution of these reporting gaps.

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 section is a planning illustration based on the observed effect, not a statement of the trial's original design calculation. For these continuous outcomes, the listed figures are participants per arm, not total participants and 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 effect to detect is set to the stated fraction of the observed effect.

The 80% power column gives the illustrated participants per arm for a design with an 80% chance of meeting its specified statistical decision rule if the assumed effect and other planning assumptions hold. The 90% column gives the corresponding illustration for a 90% chance. These are planning quantities, not counts observed in the trial. This is not observed power.

Rows describe planning for 100%, 75%, or 50% of the observed effect. A smaller effect is harder to distinguish from random variation under otherwise similar assumptions, so the illustration requires more participants per arm as the target effect becomes smaller. This relationship is visible across the rows in the table and curve. The figures are sensitive to the observed effect used as their starting point, and the observed estimate itself is uncertain.

The registry record does not report the original sample-size justification or the assumptions used by investigators when designing the study. The displayed illustrations should therefore be read as a way to explore hypothetical future planning under the listed assumptions, not as a reconstruction of the trial's intended sample size. They do not show whether the completed study was adequately powered, and they do not change the uncertainty in the posted confidence intervals.

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 = -6.300; pooled standard deviation σ = 9.459.
2. n = 2 × (1.96 + 0.842)² × 9.459² / -6.300² = 35.4, rounded up to 36 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 <- -6.3                      # observed difference in means
sigma <- 9.45911346724453                     # 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(3805607)
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 = 36 (80% power), 48 (90% power)
 75% of observed effect: n per arm = 63 (80% power), 85 (90% power)
 50% of observed effect: n per arm = 142 (80% power), 190 (90% power)
power.t.test: 36.4 
Simulated power at n = 36 per arm: 0.801 (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 identifies platelet aggregometry as the primary outcome and lists thromboelastography measures as secondary outcomes. It does not report how the investigators handled multiplicity across these endpoints. In general, testing multiple outcomes can increase the likelihood of at least one result appearing notable by chance when each is treated as a separate test. A prespecified hierarchy or statistical adjustment can help control that concern, but no such approach is reported. The secondary p-values are therefore unadjusted results, and their interpretation should remain cautious.

The record does not report missing-data methods, the number of participants with missing measurements, or reasons for any missing results. Enrollment is listed as 40; the primary endpoint results include 14 participants in the placebo arm and 17 in the ketorolac arm. The adverse-event section lists 20 participants at risk in each arm. These figures refer to different parts of the record, and the record does not explain their relationship. It would be inappropriate to infer that the differences represent missing observations, exclusions, or a particular analysis choice.

The registry record does not identify an intention-to-treat population, a per-protocol population, or another analysis population. It also does not state whether participants were analyzed according to randomized assignment or whether any participants were excluded after randomization. These details affect how readers assess the protection offered by randomization and how broadly the posted estimates apply to the enrolled participants.

The record also does not report baseline outcome values, covariate adjustment, a protocol-defined primary analysis, or the method used to construct the confidence intervals. The analysis listing contains no reported analyses. These absences limit reproducibility and make it difficult to distinguish planned analyses from analyses selected after results were observed. They do not invalidate the posted summary statistics, but they constrain how much can be concluded about the analysis process.

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% reporting threshold.

The adverse-event section lists 20 participants at risk in each group. For both placebo and ketorolac, it reports 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse-event terms are listed. These are the figures in the registry record, and they should be read as reported counts rather than as a detailed safety analysis.

The section does not provide event definitions, collection procedures, follow-up duration, or a breakdown of event types beyond the absence of listed serious terms. It also does not explain how its at-risk counts relate to the primary endpoint counts, which are 14 for placebo and 17 for ketorolac. The record does not report whether all participants had the same safety follow-up or whether any events were excluded from the posted counts.

In general, a reported count of zero is not proof that an event cannot occur; it means that none were recorded in the stated group and reporting frame. The registry record does not provide enough detail to quantify how informative these counts are about uncommon events. These safety figures should not be extended beyond the reported trial record or used as a substitute for broader safety evidence.

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

The posted primary result describes a lower mean platelet-aggregation inhibition measure in the ketorolac arm than in the placebo arm, with a reported mean difference of -6.3. Its 95% confidence interval ranges from -12.41 to -0.192, and the unadjusted p-value is 0.043. This is a statistical comparison of a laboratory outcome at 15 minutes after dosing. It is not a direct result about clinical bleeding, postpartum hemorrhage, blood loss, transfusion, pain, or opioid use.

In general, a laboratory marker may help investigate a biological question, but a difference in that marker does not by itself demonstrate a difference in patient outcomes. The registry record describes platelet aggregometry as a measure of inhibition of platelet aggregation and lists clinical conditions related to bleeding and postoperative outcomes. However, it does not post primary clinical outcome results for those conditions. The trial's posted result should therefore be kept within the scope of the laboratory measurement.

The estimate also has uncertainty. The confidence interval gives a range compatible with the posted comparison under its analysis method, while the method itself is not described in the registry record. The p-value is unadjusted, and the record does not report how multiple outcomes were handled. The secondary outcomes do not all show the same direction, and their intervals include zero. The numerical MA results are not reported in the registry record.

Several design and reporting details remain unclear, including why the primary endpoint counts are smaller than the enrollment figure, which analysis population was used, how missing data were handled, and whether any baseline adjustment was made. Thus, the result can be described accurately as a posted short-term group comparison, but the registry record alone does not support broader claims about clinical effects, the full course of platelet function, or effects in populations beyond those represented by the posted analysis.

17. Why This Trial Matters Statistically

This trial illustrates the distinction between measuring a biological response and measuring a clinical outcome. The primary endpoint is a laboratory measure of platelet aggregation inhibition, collected at a stated time after dosing. Such endpoints can address a mechanistic question, but readers need to keep the endpoint's scope separate from outcomes such as bleeding or blood loss. The registry record lists several clinical conditions but reports the primary result for platelet aggregometry.

It also shows why an estimate should be read together with its uncertainty. The mean difference and confidence interval communicate both the direction and a range of plausible magnitudes under the analysis used. The unadjusted p-value alone cannot show how precise or important a result is. The posted interval and the endpoint definition provide essential context for interpreting the comparison.

The record highlights practical challenges in registry-based statistical interpretation. Enrollment, endpoint analysis counts, and adverse-event at-risk counts are not the same figures, and the record does not explain their relationship. The absence of a stated analysis population, missing-data strategy, multiplicity approach, and detailed statistical method limits reproducibility. Such omissions do not erase the posted data, but they make clear which questions remain unanswered.

Finally, the planning illustrations demonstrate how sample-size requirements depend on the effect a future study aims to detect and the assumptions used. They are not a retrospective measure of the completed trial's success or power. Separating planning calculations from observed results is important when interpreting trials with small endpoint analysis counts and uncertain precision.

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 primary endpoint is recorded at 15 minutes after dosing. The registry record does not report additional primary measurements at later times, so the posted result does not describe duration or change over time. The assay description identifies percentage of light transmission and percentage inhibition, but further procedural details are not reported in the registry record.

The endpoint table lists 14 placebo participants and 17 ketorolac participants, whereas enrollment is 40. The safety section lists 20 at-risk participants in each group. The record does not explain these different counts, identify the analysis populations, or describe missing observations. This limits assessment of completeness and the relationship between randomization and the analyzed groups.

The primary and secondary results are summary comparisons. The specific inferential method, confidence-interval construction, baseline handling, and missing-data methods are not reported in the registry record. Nor does the record state whether secondary outcomes were adjusted for multiplicity. MA is a named secondary outcome without numerical results, leaving the posted secondary results incomplete relative to the listed outcomes.

The record also does not provide detailed eligibility criteria, protocol deviations, treatment adherence, or the practical procedures used to maintain quadruple masking. These limits are specific to what is documented; they should not be taken as evidence that such procedures were absent. The reported adverse-event counts have limited accompanying detail, including no stated follow-up description or event-collection method. Together, these gaps mean that the posted comparisons can be described, but the registry record alone cannot resolve all questions about conduct, analysis, or generalizability.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: IV Ketorolac on Platelet Function Post-Cesarean Delivery — NCT03805607.
• Registry record last updated 2026-05-29; status last verified 2026-05.
• Results first posted 2026-05-29.
• 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

The registry record describes a completed Phase 4 randomized, quadruple-masked, parallel-group study of ketorolac versus saline placebo after cesarean delivery. Enrollment is listed as 40. The primary endpoint is platelet aggregometry 15 minutes after dosing. The posted primary mean difference is -6.3, with a 95% confidence interval from -12.41 to -0.192 and an unadjusted p-value of 0.043.

Numerical secondary results are posted for three thromboelastography measures; MA is listed but numerical results are not reported in the registry record. The adverse-event section reports zero serious events, zero other events, and zero deaths in each group. The record does not describe the statistical analysis plan, analysis populations, missing-data handling, or multiplicity approach, and it does not explain the differing participant counts across sections. The posted findings are laboratory comparisons and do not directly report clinical bleeding or other patient outcomes.