Improving Medication Adherence in Adolescents Who Had a Liver Transplant: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Medication Adherence in Adolescents Who Had a Liver Transplant (NCT03691220), a randomized na study. The primary outcome is Number of Participants Experiencing at Least One Episode of Rejection.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with single masking. The registry record lists the phase as NA and the study status as completed. Enrollment was 148. The study start date was 2018-11-14, and the primary completion date was 2025-10-22. The sponsor was Icahn School of Medicine at Mount Sinai.

Participants were adolescents who had received a liver transplant and had MLVI >2. The trial compared a behavioral telemetric intervention with standard of care. Both arms were described as involving adolescents with MLVI >2, with the assigned group receiving either the telemetric intervention or standard care. The registry record does not say which people were masked or give further details about masking procedures.

The primary outcome was the number of participants experiencing at least one episode of rejection during 2 Years. The registry description specifies biopsy-proven acute cellular rejection during follow-up and describes a centrally assessed component based on readings by three masked pathologists who were not from the participant’s clinical site. It also states that participants with incomplete follow-up, for example due to death, re-transplant, or listing for re-transplantation, were assumed to have experienced rejection for the primary analysis.

Other registered outcomes covered tacrolimus-level variability, rejection events, time to rejection, death, re-listing for transplantation, and ALT. The registry record does not report the original sample-size justification, detailed treatment procedures, a full analysis plan, or the identities of the people who were masked.

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants Experiencing at Least One Episode of Rejection, measured over 2 Years.

The primary endpoint counts participants who experienced at least one episode of biopsy-proven acute cellular rejection during 2 Years of follow-up. It is a participant-level event outcome: a participant is counted if at least one qualifying episode occurred, rather than being counted repeatedly for each episode. The registry description specifies late acute rejection confirmed by biopsy and says the central determination was based on the majority reading of liver biopsy images by three masked pathologists who were not from the clinical site where the participant was treated.

This endpoint is used to summarize whether participants experienced rejection during the stated follow-up period. Counting participants with at least one event gives an interpretable comparison of event occurrence between the randomized arms, while not expressing how many total episodes each participant experienced. The registry description also says participants with incomplete follow-up, including circumstances such as death, re-transplant, or listing for re-transplantation, were assumed to have experienced rejection for the primary analysis.

The posted counts were 6 of 72 participants in the telemetric intervention arm and 12 of 76 in standard care. The registry record does not report a sponsor-conducted analysis for this outcome.

7. Results Posted in the Registry

• Telemetric Intervention Arm: 8.3% (6/72) versus 15.8% (12/76) on control; risk difference -7.5 percentage points (95% CI -17.8 to 2.9), risk ratio 0.53 (0.21–1.33); unadjusted two-proportion z-test p = 0.165.

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.

The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)

• 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:
  • Telemetric Intervention Arm: mean 2.10 versus 2.30 on control; difference -0.20 (95% CI -0.72 to 0.32), standardized effect d = -0.12; z-test p = 0.452.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Telemetric Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up

• 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:
  • Telemetric Intervention Arm: mean 0.20 versus 0.20 on control; difference 0.00 (95% CI -0.15 to 0.15), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Telemetric Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

Time to First Locally Rejection From Enrollment

• 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:
  • Telemetric Intervention Arm: mean 5.60 versus 8.30 on control; difference -2.70 (95% CI -6.37 to 0.97), standardized effect d = -0.60; z-test p = 0.149.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Telemetric Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several domains: variability in tacrolimus levels, rejection occurrence and counts, time to rejection, death, re-listing for transplantation, and ALT. Their measures differ, and their follow-up descriptions are not all identical. Taken together, they provide additional descriptive context around the primary rejection endpoint, but they do not form a single consistent or independently confirmatory test of the primary comparison.

The posted secondary results include continuous summaries and event-related outcomes. Their levels of precision vary, and some are based on fewer participants or events than the primary comparison. This means that secondary estimates can be especially uncertain, and their apparent direction or size should not automatically be taken as corroborating or contradicting the primary result. They address related but not interchangeable questions: for example, an adherence-related measure and a biopsy-determined rejection outcome do not measure the same construct.

The registry record lists 11 posted secondary outcomes but no reported analyses for them. The posted summary statistics permit descriptive comparisons, yet the record does not document a hierarchy of secondary hypotheses or a multiplicity procedure. When many outcomes are examined, some may look notable by chance even if no underlying effect exists. Unadjusted secondary results therefore carry less evidential weight than a prespecified primary result with a clearly documented analysis plan.

Secondary findings can still help identify patterns that merit careful study, especially when considered with their definitions, denominators, and uncertainty. They should not be read as proof of a mechanism or as evidence that the intervention changes adherence simply because adherence-related and clinical outcomes appear in the same registry. The registry record does not report mediation analyses linking changes in MLVI to rejection outcomes. Nor does it report a sponsor-conducted inferential analysis of the secondary endpoints.

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

• The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
• Number of Participants With Locally and Centrally Determined Rejection by Biopsy
• Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up
• Time to First Locally Rejection From Enrollment
• Time to First Centrally Determined Rejection
• Occurrence of Death
• Occurrence of Re-Listing For Transplantation
• Number of Participants With ALT >150 U/L

9. Statistical Interpretation

10. Statistical Methods Explained

What the primary comparison represents. The primary outcome is binary at the participant level: each participant is classified according to whether at least one qualifying rejection episode occurred during 2 Years of follow-up. The posted arm counts are 6 of 72 and 12 of 76. The risk difference is an absolute comparison between the two event proportions, with the intervention arm compared against standard care. Its estimate, -0.075, is expressed as a difference in proportions. The posted 95% confidence interval is -0.178 to 0.029.

General: interpreting a confidence interval. A confidence interval describes the precision of an estimate under the assumptions of the statistical method used. In repeated applications of a method, intervals constructed in this way would cover the underlying parameter at the stated rate. It is not a range that assigns a probability to the true value after the data have been observed. For the primary risk difference, the interval extends from a negative difference to a positive difference and includes zero. That span reflects uncertainty about both the size and direction of the underlying difference.

Relative measures. The registry-derived comparison also reports a risk ratio and an odds ratio. A risk ratio compares the event proportions between arms; an odds ratio compares the event odds. The posted risk ratio is 0.528, with interval 0.209 to 1.332. The posted odds ratio is 0.485, with interval 0.172 to 1.37. Each measure uses a different scale, so its numerical value should be interpreted according to that scale rather than treated as interchangeable with the risk difference. The intervals include the no-difference value for their respective measures.

Unadjusted comparisons. The comparisons posted for the outcomes are simple unadjusted recalculations from summary statistics. They are not described as adjusted for baseline factors or other variables. An unadjusted comparison is a direct summary of the observed arm results; it does not account for possible imbalance in participant characteristics. The registry record does not list a sponsor-reported analysis for the primary endpoint or reported analyses for the posted secondary outcomes. The registry record also does not report the statistical test or model used in the trial’s original analysis.

General: randomized parallel-group design. Random allocation is intended to make treatment groups comparable on average, including for characteristics not measured in the study. A parallel-group design assigns participants to one of the study arms and compares the groups. Randomization does not guarantee exact balance in a particular trial, and the registry record does not provide a baseline table in the registry record. Single masking indicates that masking was designated, but the record does not specify who was masked. These design labels do not substitute for details about implementation or analysis.

General: counts and over-dispersion. A binary participant endpoint records whether an event occurred, while a count endpoint can include more than one event per participant. For counts, the spread of values can differ from what a simple statistical model assumes. Over-dispersion means that observed variability is greater than a model’s assumed variability; if unaccounted for, uncertainty can be understated. The registry’s posted secondary count outcome is a mean number of locally determined rejections per patient, but the record does not report a count-model analysis or an assessment of over-dispersion. The summary statistics alone do not establish which model would be appropriate.

Continuous outcomes and time outcomes. The tacrolimus-level variability outcome and the listed rejection counts are presented as means with standard deviations. A mean difference summarizes the difference between the arm means; the standard deviation describes participant-level variation, not uncertainty in the mean difference. The time-to-first-local-rejection outcome is posted as means in months, although its label refers to time until an event. The registry record does not report a survival analysis, censoring details, or a sponsor-reported analysis for that outcome. It is therefore important not to infer a particular time-to-event model from the outcome label alone.

Multiplicity and interpretation. Multiple outcomes and comparisons create more opportunities for chance findings. The registry record lists 12 outcome measures, including the primary endpoint, and 11 posted secondary outcomes. It does not report multiplicity adjustment, an outcome hierarchy, or a prespecified rule for interpreting secondary results. Unadjusted secondary p-values, where posted, should be viewed as descriptive evidence rather than as a set of independent confirmatory tests.

Analysis populations and missing data. The primary endpoint description gives a specific rule for incomplete follow-up: participants with incomplete follow-up due to examples such as death, re-transplant, or listing for re-transplantation were assumed to have experienced rejection for the primary analysis. The record does not describe other missing-data procedures, the analysis population, or whether all randomized participants were included in each analysis. The group denominators for the primary outcome are 72 and 76; outcome-specific secondary denominators vary. Reasons for those varying denominators are not reported in the registry record.

11. Confidence Intervals and Precision

The primary risk-difference estimate is -0.075, and its 95% confidence interval extends from -0.178 to 0.029. This interval includes zero and spans negative and positive values, so the primary estimate is not highly precise about the direction of the underlying difference. It permits a range of effects rather than identifying one exact value. The posted unadjusted p-value, 0.165, is consistent with that uncertainty but is not a measure of the interval’s width or of the probability that the intervention has a particular effect.

The relative estimates tell a similar precision story. The risk ratio is 0.528, with an interval from 0.209 to 1.332; the odds ratio is 0.485, with an interval from 0.172 to 1.37. Both intervals include the no-difference value on their respective scales and extend across a broad range of possible relative effects. The differing scales should be kept in mind when comparing the estimates.

General: A confidence interval is informative because it combines the estimated effect with its uncertainty. A wide interval signals that the data do not locate the underlying effect narrowly; a narrow interval indicates greater precision under the method’s assumptions. An interval crossing the no-difference value does not prove that the groups are identical. Nor does an interval that lies on one side of that value, by itself, establish clinical importance. The registry record does not define a threshold for a clinically important difference.

Precision is also affected by the number of participants contributing to an outcome and by the number of observed events. The primary comparison has 72 and 76 participants in the two arms, with 6 and 12 recorded events. The registry record does not provide a precision target or a sponsor’s original sample-size justification, so the observed interval cannot be judged against a reported design goal.

12. Planning a Similar Trial: Sample Size

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

The planning figures are illustrations based on the observed effects, not the trial’s original design assumptions. The registry record does not report the trial’s own sample-size justification or its original planning assumptions. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; each row considers detecting the stated fraction of the observed effect.

For the primary binary outcome, the figures are participants per arm. At 100% of the observed effect, the illustration gives 299 participants per arm for 80% power and 399 participants per arm for 90% power. At 75% of the observed effect, the corresponding figures are 567 and 758 participants per arm; at 50%, they are 1,353 and 1,811 participants per arm. The planning figures for the tacrolimus-level variability outcome are also participants per arm. For the time-to-first-local-rejection planning figures, the stated convention is total events rather than participants per arm.

The 80% power column describes the sample size that, under the illustration’s assumptions, would give an 80% chance of detecting the stated effect using the specified significance level. The 90% column uses the same idea with a higher chance of detection. These are design-planning quantities, not observed power. Smaller effects require more participants, or more events for the time-to-event figures, to reach the same planned power under the stated assumptions. The illustrations should not be treated as a reconstruction of the completed trial’s original design rationale.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Control proportion p₀ = 0.158; treatment proportion p₁ = 0.083; average p̄ = 0.121.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4606 = 0.9027.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4576 = 0.3851.
4. n = (0.9027 + 0.3851)² / (-0.0746)² = 298.3, rounded up to 299 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 <- 0.157894736842105                          # control proportion
p1 <- 0.0833333333333333                          # 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(3691220)
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 = 299 (80% power), 399 (90% power)
 75% of observed effect: n per arm = 567 (80% power), 758 (90% power)
 50% of observed effect: n per arm = 1,353 (80% power), 1,811 (90% power)
power.prop.test: 298.3 
Simulated power at n = 299 per arm: 0.812 (20000 replicates)

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

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary endpoint and 11 posted secondary outcomes. It does not report whether the trial used a multiplicity adjustment, a gatekeeping procedure, or a prespecified order for testing secondary outcomes. This matters because examining many outcomes increases the chance that at least one result will appear notable by chance. Without a stated plan for controlling that risk, individual unadjusted secondary results should be treated as exploratory rather than as a collection of confirmatory findings.

The record also does not report a complete statistical analysis plan, the original sample-size justification, interim analyses, or the planned treatment of all analysis populations. The primary outcome description does include a rule for incomplete follow-up: participants with incomplete follow-up, including examples such as death, re-transplant, or listing for re-transplantation, were assumed to have experienced rejection for the primary analysis. That endpoint-specific rule is important when interpreting the primary count, but it does not disclose how other missing values or secondary outcomes were handled.

The primary group denominators are 72 and 76. The secondary outcome denominators vary, including outcomes with fewer participants contributing. Reasons for differences in denominators, exclusions, and missing observations are not reported in the registry record. The registry record does not specify whether the reported comparisons followed an intention-to-treat population, a per-protocol population, or another defined analysis set.

The registry record contains no sponsor-reported analyses for the primary endpoint and no reported analyses for the posted secondary outcomes. The comparisons described in the statistical interpretation are unadjusted recalculations from posted summary statistics. They are useful for describing the arm-level data and their uncertainty, but they cannot establish what model or analysis population the investigators prespecified. The record does not report an interim-monitoring plan or stopping rules, so no conclusions about those procedures can be drawn.

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 registry reports 0 serious adverse events among 72 participants at risk in the telemetric intervention arm and 0 among 76 participants at risk in standard care. It also reports 0 other adverse events in each arm, with the same respective numbers at risk. Deaths are listed as 0 in both arms. No serious adverse event terms are listed.

These figures describe what was recorded in the registry for the reported groups. They should not be interpreted as proof that no adverse events occurred or that the intervention has no safety risks. The registry record does not provide further detail on event definitions, collection procedures, reporting windows, or whether all events were captured in the same way across arms. The zero counts also do not establish a safety difference between the groups; the record does not report a comparative safety analysis.

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

The primary posted results show fewer participants with at least one recorded rejection in the telemetric intervention arm than in standard care. The unadjusted risk difference is -0.075, with a 95% confidence interval from -0.178 to 0.029 and an unadjusted p-value of 0.165. The interval includes zero and allows effects in either direction. The data therefore do not provide a precise estimate of the direction or size of the underlying difference.

This result does not establish that the intervention reduces rejection, and it does not establish that the two approaches are equivalent. A failure to distinguish the observed groups using a conventional significance test is not evidence that their effects are identical. The registry record does not report an equivalence or non-inferiority margin, nor does it give a sponsor-reported analysis to support a different interpretation.

The study aim connects the intervention to medication adherence and rejection incidence, but the posted primary endpoint is rejection, not a direct estimate of a causal pathway from telemetric support through adherence to rejection. The registry record lists tacrolimus-level variability as a secondary outcome, but it does not report a mediation analysis. A change in one measure should not be assumed to explain a change in another without a specified analysis.

The findings apply to the trial’s stated population: adolescent liver transplant recipients identified by MLVI >2. The registry record does not report enough detail to infer how results would apply to other populations or settings. The trial also has several secondary outcomes with no reported analysis plan or multiplicity procedure. Those outcomes can add context, but they do not replace the primary comparison or resolve its uncertainty.

Finally, the registry’s incomplete-follow-up rule is part of the primary endpoint definition: specified cases of incomplete follow-up were assumed to have experienced rejection. That rule shapes the estimand represented by the posted outcome and should be kept in mind when comparing the primary result with results from studies using different rules. Further detail about other missing data and analysis populations is not reported in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically informative because it evaluates a randomized comparison for a clinically consequential endpoint in a defined group of adolescent liver transplant recipients. The primary result combines an interpretable event count with an absolute difference and relative measures. Reading the estimate together with its confidence interval makes the uncertainty visible rather than reducing the evidence to a binary conclusion based on a p-value.

The record also illustrates why the outcome definition matters. The primary endpoint counts participants with at least one biopsy-proven rejection episode, and it specifies how some forms of incomplete follow-up were treated. The endpoint therefore reflects both the clinical event definition and the registry’s stated handling rule. Those details affect what the comparison means and how it can be compared with other analyses.

A further statistical lesson is the distinction between a trial’s own design and later planning illustrations based on observed effects. The planning figures are conditional illustrations under explicit assumptions; they do not reveal the original justification for enrollment. The registry record does not report that original justification. Keeping design information separate from post hoc planning prevents the observed data from being mistaken for evidence that a study was adequately or inadequately powered under its original plan.

Finally, the trial has numerous secondary outcomes and no reported analyses for them. That makes transparent attention to uncertainty, multiplicity, denominators, and missing-data rules especially important. The primary estimate is informative, but its interval and the limitations of the registry record define how strongly it can be interpreted.

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 several trial-specific uncertainties. It does not report the original sample-size justification, detailed protocol assumptions, a full statistical analysis plan, or any interim-analysis procedures. Consequently, the planning illustrations based on the observed effects cannot explain the enrollment target or establish how the original design was expected to perform.

The record identifies the trial as single-masked but does not state who was masked or describe how masking was maintained. It does not provide detailed intervention content, the delivery schedule, or the content of standard care. These omissions limit assessment of implementation and the extent to which the two arms differed beyond their assigned labels.

The primary outcome description includes an explicit assumption for certain incomplete-follow-up situations, but the record does not explain how other missing observations were handled. Reasons for the different outcome-specific denominators are also not reported. This is particularly relevant to secondary outcomes with fewer participants or events, for which estimates may be less precise.

Although multiple outcomes are listed, the record does not report multiplicity control, a hierarchy of hypotheses, or reported analyses for the secondary endpoints. The outcome summaries therefore do not establish which secondary comparisons, if any, were intended as confirmatory. The record also does not report baseline characteristics or a detailed account of the analysis populations, limiting assessment of balance and inclusion rules.

Finally, the primary result is based on a relatively small number of recorded events compared with the group sizes, and its confidence interval includes differences in both directions. The registry record does not provide additional sponsor-reported analysis to resolve that uncertainty. These limitations call for restrained interpretation of the observed comparison, rather than a conclusion that the groups are the same or different with certainty.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Improving Medication Adherence in Adolescents Who Had a Liver Transplant — NCT03691220.
• Registry record last updated 2026-09-30; status last verified 2026-09.
• Results first posted 2026-09-30.
• 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 describes a completed randomized, single-masked, parallel-group study sponsored by Icahn School of Medicine at Mount Sinai. It enrolled 148 adolescents with liver transplants identified as having MLVI >2 and compared a behavioral telemetric intervention with standard care. The primary endpoint was at least one biopsy-proven rejection episode during 2 Years of follow-up.

The posted primary counts were 6 of 72 in the intervention arm and 12 of 76 in standard care. The unadjusted risk difference was -0.075, with a 95% confidence interval from -0.178 to 0.029 and an unadjusted p-value of 0.165. The interval includes no difference and leaves uncertainty about the direction and size of the underlying effect. The record lists 11 posted secondary outcomes, reports zero serious and other adverse events and zero deaths in both arms, and does not include sponsor-reported analyses.