A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis (NCT03000673), a randomized phase 1, phase 2 study. The primary outcome is The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death.

2. Clinical Question

The study addresses a safety question in a specific clinical setting: use of single oral doses of BMS-986177 in people with end-stage renal disease who are treated with chronic hemodialysis. The registry describes the study as randomized and crossover, with no masking. It lists sequences containing BMS-986177, unfractionated heparin, and enoxaparin. The sequences vary in the order of these treatments and in the order of BMS-986177 dose 1 and dose 2.

The primary outcome is descriptive: it counts participants with adverse events, serious adverse events, adverse events leading to discontinuation, and deaths. It is not an efficacy comparison, and the registry does not identify a single treatment contrast as the primary question. Although the sequence descriptions include the named treatments, the registry record does not report which treatment sequence corresponds to each of the treatment labels in the posted safety summaries.

The registry reports zero for each listed adverse-event category in each treatment group. Those results describe the recorded safety outcomes for this study; they do not establish that the treatments have identical safety profiles or that events could not occur in other patients or settings. The record does not report a formal statistical comparison of the groups.

3. Trial Design

The registry classifies the study as phase 1 and phase 2, randomized, open-label, and crossover. It records enrollment of 32 and a completed status. The study start date is 2017-05-23, and the primary completion date is 2017-10-23. Bristol-Myers Squibb is listed as the sponsor.

A crossover design assigns treatment sequences, so participants may receive different treatments in a planned order rather than remaining in a single parallel treatment group. The registry lists sequences combining unfractionated heparin, enoxaparin, and two BMS-986177 dose levels. The order differs across the sequence descriptions. This design is relevant to interpretation: the treatment-group safety summaries should not automatically be read as results from independent parallel arms.

The registry record does not report the allocation ratio, the method used to generate the random sequence, or whether assignment was concealed. It also does not report the duration of any washout period or the rationale for the sequence structure. Masking is explicitly listed as none, so treatment assignment was not masked according to the record.

The primary safety observation period is described as beginning at written consent and continuing until 30 days after dosing discontinuation or the participant’s end of study participation, up to October 2017. The registry lists all treated participants as the primary outcome population. It does not provide a participant flow narrative explaining how many participants completed each sequence or contributed to each treatment-specific safety denominator. The listed denominators are 32, 32, 31, and 31, and should be read as reported for their respective treatment summaries.

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: 32 participants were randomized and treated.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All treated participants

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 The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death, measured over From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017).

The primary endpoint counts participants with adverse events, serious adverse events, adverse events leading to discontinuation, and deaths. The registry describes the measure as a number of participants, with the population defined as all treated participants. Its observation period runs from written consent through 30 days after dosing discontinuation or the end of study participation, up to October 2017.

These outcomes are used to describe safety and tolerability. Counting participants with an event gives a direct account of how many people in a treatment summary experienced a recorded event in each category. Serious adverse events and deaths capture important safety outcomes; adverse events leading to discontinuation indicate events associated with stopping participation or dosing. The broader adverse-event category records events that may not meet the serious-event definition.

The endpoint is not a single continuous measure, and it combines several event categories. The registry therefore does not reduce it to one comparison. It reports each category descriptively, without a posted statistical analysis comparing treatments. The counts alone do not describe event timing, duration, severity beyond the serious-event category, or the clinical details of individual events. Those details are not reported in the registry record.

For a crossover study, the treatment-period context and sequence can matter when interpreting safety counts. The record lists the treatment sequences but does not explain how events were attributed if they arose around transitions between treatments. That attribution procedure is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a descriptive event count tell the reader?

General explanation: a descriptive count records how many participants experienced a defined event. It is useful for showing what occurred in a study population, especially for safety outcomes. A count is not, by itself, an estimate of a treatment effect. Comparing groups statistically requires a specified comparison, an analysis method, and a clear account of the relevant participants and observation periods.

In this record, the primary outcome includes several event categories rather than one measure. The posted group summaries give counts of serious adverse events, other adverse events, and deaths. The primary outcome description also names adverse events leading to discontinuation. Because these categories are distinct, a count in one category should not be substituted for a count in another. The registry reports zero for the event categories in the group summaries, but does not supply a formal treatment contrast.

Why does the crossover design matter?

General explanation: in a crossover design, treatment order is part of the design. A participant may contribute observations under different treatments, and outcomes can depend on the period or sequence in which treatment is received. Analyses may need to account for within-participant dependence and period or sequence effects. The appropriate approach depends on the trial protocol and outcome structure; it cannot be inferred from the design label alone.

Here, the registry lists randomized crossover allocation and four dose-sequence descriptions. It does not report the statistical model used to handle repeated observations, sequence, period, or potential carryover. It also does not report a mapping from the treatment labels in the safety summaries to the listed sequence descriptions. No particular adjustment or model should therefore be assumed.

How should denominators and zero counts be read?

General explanation: a denominator indicates the participants considered at risk or eligible for an outcome summary. A count of zero means no event was recorded in that summary; it does not prove that the true event probability is zero. With no observed events, a confidence interval can help communicate the range of risks compatible with the data. The width of an interval reflects precision, and its interpretation depends on the method used to construct it.

The registry reports denominators of 32, 32, 31, and 31 for the four group summaries, with zero event counts. It does not report confidence intervals. Because the study is crossover, the denominators should not be summed to infer a number of distinct participants, and group summaries should not be assumed to represent independent groups of people.

What is absent from the statistical reporting?

The registry record lists 22 outcome measures and no statistical analyses. It does not report p-values, confidence intervals, treatment-effect estimates, or a specified model for the primary safety outcome. The primary outcome comprises multiple event categories, and the record does not reduce those categories to one comparison. The analysis plan, including any prespecified contrasts or adjustment strategy, is not reported in the registry record.

General explanation: a p-value addresses compatibility between data and a specified statistical model under a null hypothesis; it is not a measure of clinical importance or a probability that a treatment is safe. A confidence interval describes statistical uncertainty around an estimate under its assumptions. Neither can be interpreted meaningfully without knowing the estimate, comparison, and method. No such inferential results are posted for this outcome, so they should not be reconstructed from the counts as if they were sponsor-reported analyses.

What do planning calculations represent?

General explanation: a sample-size calculation is a planning exercise. It asks how much information might be needed to detect a chosen effect under stated assumptions. It is not a measure of what the completed study actually had the power to find, and it does not turn observed results into evidence of equivalence. A calculation based on an observed effect is especially dependent on that effect and on the assumptions chosen for the illustration.

The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. It also distinguishes participant counts per arm from total event counts for time-to-event calculations. These are described as planning assumptions, not as the trial’s own design justification. The registry record does not report the original sample-size justification or a statistical analysis plan for the primary endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The primary safety outcome contains several categories: adverse events, serious adverse events, events leading to discontinuation, and deaths. The registry also lists 22 outcome measures, including pharmacokinetic measures. Testing multiple outcomes or treatment contrasts can raise multiplicity concerns because the chance of at least one apparently notable result can increase when many tests are considered. General statistical practice may address this through prespecification, adjusted inference, or careful descriptive interpretation. The registry record does not report a multiplicity strategy.

No statistical analyses are reported for the listed outcomes. The record does not identify a hierarchy of primary and secondary hypotheses beyond the stated primary outcome, nor does it report adjustment for repeated testing. Since the safety results are reported as counts and the primary outcome has multiple categories, no single inferential result should be inferred from them.

The record defines the primary outcome population as all treated participants, but does not describe how missing outcome information was handled. It does not report whether any participants withdrew, missed assessments, or had incomplete follow-up, nor does it give rules for handling such cases. The registry record does not report an intention-to-treat population, a per-protocol population, or additional analysis populations for the primary endpoint.

The stated observation period extends through 30 days after dosing discontinuation or the end of study participation, up to October 2017. The record does not explain how partial observation periods or events with uncertain treatment attribution were handled. The absence of those details limits assessment of completeness and comparability across treatment summaries. It should not be taken as evidence that data were missing or that a particular method was used.

11. 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 5% reporting threshold.

For Treatment A, Treatment B, Treatment C, and Treatment D, the registry reports zero serious adverse events, zero other adverse events, and zero deaths. The reported numbers at risk are 32, 32, 31, and 31, respectively. The primary outcome also includes adverse events leading to discontinuation, and the posted group summaries report no events in the listed categories.

These figures are event counts within treatment summaries, not proof that the treatments carry no risk. A zero count means no event of that category was recorded in the corresponding summary during the stated follow-up. It does not determine the underlying event rate, and no confidence intervals are reported to describe the uncertainty around the counts.

The study uses a crossover design. The treatment summaries should not be interpreted as separate parallel groups without accounting for the sequence structure, and the denominators should not be added to count distinct participants. The registry does not report the mapping between the treatment labels and the listed dose sequences, or a statistical method for comparing safety across them.

The registry record does not provide event narratives or information on severity beyond the serious-event classification. The counts therefore support a limited descriptive reading: the listed summaries contain no recorded events in these categories. They do not establish safety under other dosing patterns, longer exposure, or different patient populations.

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

The posted results describe a completed randomized, open-label crossover study of single oral BMS-986177 doses in patients with end-stage renal disease receiving chronic hemodialysis. In the registry’s safety summaries, the reported counts for serious adverse events, other adverse events, and deaths are zero in each treatment group. The record also identifies adverse events leading to discontinuation as part of the primary outcome.

These results are useful as a description of the events recorded during the study’s stated observation period. They show what the registry reports for the groups and denominators listed. They do not establish that the treatments are equally safe, that risk is absent, or that an event could not occur under other conditions. The study’s event counts are not accompanied by confidence intervals or formal statistical comparisons in the registry record.

The finding should be understood in the context of the design and exposure described. Participants were assigned to treatment sequences, and the record focuses on single doses. It does not establish the safety profile of repeated treatment, longer use, or use in people outside the specified hemodialysis population. The record also does not provide detailed adverse-event descriptions that would allow assessment of event type, timing, or clinical course.

More broadly, an absence of observed events in a study is not the same as evidence that the underlying risk is zero. Statistical uncertainty remains, and the registry does not quantify it for these results. The record’s lack of a reported analysis also means that no adjusted comparison or claim of equivalence can be drawn from the posted counts alone.

13. Why This Trial Matters Statistically

This study is statistically relevant because it evaluates safety in a defined population and uses a crossover design with several treatment sequences. Crossover studies can provide within-participant comparisons, but interpretation depends on sequence, period, and repeated-observation structure. The registry identifies the design but does not report the statistical approach used to address those features. That gap matters when reading treatment-specific safety summaries.

The event counts are also a useful reminder that descriptive results and inferential conclusions are different. Zero reported events in the listed categories is a clear account of what the registry records, but it does not quantify the uncertainty around the underlying risk. Without confidence intervals or a specified statistical comparison, the reader cannot assess precision or infer that treatment risks are equivalent.

The primary outcome combines several safety categories, while the registry lists 22 outcome measures. This makes transparent reporting of outcome definitions, analysis populations, missing-data handling, and multiplicity methods important. Those details are not reported in the registry record. The available results can still be read as descriptive observations, but they do not answer every statistical question about the study.

Finally, the trial’s stated focus is specific: single doses in patients with end-stage renal disease receiving chronic hemodialysis. The registry record does not support extrapolation to other populations or dosing contexts. The value of the results is therefore in their bounded description, alongside a clear recognition of what the record does not report.

14. 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 describes a randomized, open-label crossover design and lists treatment sequences, but does not report the randomization method, allocation ratio, allocation concealment, or any washout details. It also does not map the treatment labels in the safety summaries to the sequence descriptions. These omissions make it difficult to reconstruct how the reported treatment summaries relate to treatment order.

The safety counts are descriptive and all listed event counts are zero. The record does not report confidence intervals, formal comparisons, or the model used for safety outcomes. As a result, statistical precision and possible differences between treatments cannot be assessed from the registry results. The record also does not provide event narratives, timing, or severity information beyond the serious-event category.

The primary population is described as all treated participants, but there is no participant flow account or explanation of the denominators of 32 and 31. The registry does not report missing-data procedures, incomplete follow-up, or how events around treatment transitions were attributed. These details are relevant in a crossover study, but their absence should not be interpreted as proof that missingness or attribution problems occurred.

The registry lists 22 outcome measures and no statistical analyses. It does not report a multiplicity approach, an analysis plan, or the original sample-size justification. The study concerns single doses in a specific hemodialysis population, so the record does not establish results for repeated dosing, longer-term use, or other populations. These limitations constrain both the precision and the scope of conclusions drawn from the posted data.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis — NCT03000673.
• Registry record last updated 2020-12-29; status last verified 2020-12.
• Results first posted 2020-12-29.
• 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.

18. Record Summary

The registry describes a completed phase 1 and phase 2 randomized, open-label crossover study sponsored by Bristol-Myers Squibb. It enrolled 32 participants and examined safety and tolerability of single oral BMS-986177 doses in patients with end-stage renal disease receiving chronic hemodialysis. The listed treatment sequences include BMS-986177 dose 1 and dose 2, unfractionated heparin, and enoxaparin.

The primary outcome counts participants with adverse events, serious adverse events, events leading to discontinuation, and deaths, from written consent through 30 days after dosing discontinuation or the end of participation. The group summaries report zero serious adverse events, other adverse events, and deaths for each treatment label, with reported numbers at risk of 32, 32, 31, and 31.

The registry lists 22 outcome measures and no statistical analyses. It does not report confidence intervals, a formal treatment comparison, or details of missing-data handling and multiplicity. The results are therefore descriptive and specific to the population, doses, and observation period in the record.