This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) (NCT02839889), a randomized phase 4 study. The primary outcome is Numerical Rating Scale (NRS) for Pain Change From Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02839889 |
| Phase | Phase 4 |
| Condition | Cancer, Constipation, Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 12 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Hospice of Henderson County, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with cancer, pain, and opioid-induced constipation were the intended study population. The registry lists cancer, constipation, and pain as conditions. The primary outcome summary includes 2 participants in the placebo arm and 3 in the naloxegol arm; the registry record lists enrollment of 12. The record does not explain the difference between enrollment and the counts contributing to this outcome.
Intervention
The intervention was naloxegol 25mg tablets once daily for two weeks during the randomized period. The registry describes a subsequent two-week open-label period but does not report its treatment details in the record.
Comparator
The comparator was placebo once daily for two weeks. The trial was randomized, parallel, and quadruple-masked during the blinded period, according to the registry.
Primary question
The primary outcome was change from baseline in mean daily Numerical Rating Scale pain scores. The scale runs from 0 for no pain to 10 for worst possible pain; lower values are better. The posted summaries describe changes in each arm, but a two-arm treatment-effect estimate is not reported in the registry record.
The registry describes the study purpose as assessing the tolerability, safety, and feasibility of naloxegol for opioid-induced constipation in patients with cancer and pain. The primary endpoint, however, concerns pain scores rather than a bowel-movement outcome. The listed secondary outcomes address bowel function and constipation-related symptoms and quality of life, including rescue-free bowel movements, time to first post-dose rescue-free laxation, stool form, and patient-reported measures.
The distinction between the stated study purpose and the posted primary endpoint matters when interpreting the results. The primary data answer a descriptive question about pain-score change among the participants included in the posted arm summaries. They do not, by themselves, establish a comparative effect on constipation outcomes. A complete treatment comparison for the secondary outcomes is not reported in the registry record.
3. Trial Design
This was a phase 4, randomized, parallel-group study sponsored by Hospice of Henderson County, Inc. The registry reports that enrollment was 12, the study started in 2016-09, and primary completion was 2018-01-11. Its status is terminated. The reason for termination is not reported in the registry record.
The brief description outlines a two-week randomized, double-blind period followed by a two-week open-label period. The registry separately classifies masking as quadruple. These descriptions indicate that the initial treatment period was intended to be blinded, followed by an open-label phase; further operational details about who was masked, the transition between periods, or treatment assignment during the open-label phase are not reported in the registry record. The naloxegol arm received 25mg tablets once daily for two weeks, while the placebo arm received placebo once daily for two weeks.
The primary outcome timeframe is described as extending from screening and the opioid-induced constipation confirmation period through study completion, approximately 6 weeks. Baseline NRS was defined as the mean daily values recorded during the confirmation period. Post-baseline values were calculated as the mean of NRS scores during visits 2-4. The registry does not report additional visit-level details or the timing of each measurement.
Although the registry reports enrollment of 12, the posted primary outcome summaries include 2 participants in the placebo arm and 3 in the naloxegol arm. The record does not explain why fewer participants appear in those summaries, whether other participants lacked measurements, or which analysis population was intended. The trial's status and the small number of participants represented in the primary outcome summaries limit how much can be learned from the posted results. A protocol, detailed statistical analysis plan, and sample-size justification 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.
Before assignment: To confirm eligibility participants underwent a 7 day baseline assessment/OIC confirmation period. 12 patients provided consent for this study, however 7 did not fulfill eligibility criteria during the 7 day baseline period.
Randomization Period
| Stage | Placebo | Naloxegol |
|---|---|---|
| STARTED | 2 | 3 |
| COMPLETED | 2 | 3 |
| NOT COMPLETED | 0 | 0 |
Open-Label Period
| Stage | Placebo | Naloxegol |
|---|---|---|
| STARTED | 0 | 5 |
| COMPLETED | 0 | 4 |
| NOT COMPLETED | 0 | 1 |
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.
| Characteristic | Unit | Placebo | Naloxegol | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 3 | 5 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Female | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 2 | 3 | 5 |
| Baseline Numerical Rating Scale (NRS) for Pain | score on a scale | 5.7 (5.1 to 6.3) | 6.2 (5.4 to 7.1) | 6.0 (5.1 to 7.1) |
| Baseline Electrocardiogram QTC Interval | Milliseconds | 430.8 (423 to 438.5) | 414.5 (381.6 to 447) | 421 (381.6 to 447) |
| Baseline Electrocardiogram Heart Rate | beats per minute | 82 (80 to 84) | 79 (66 to 98) | 80.2 (66 to 98) |
| Baseline Daily Opioid Use | morphine milligram equivalents per day | 300 (240 to 360) | 126.5 (40 to 300) | 196 (40 to 360) |
| Baseline Systolic Blood Pressure | mmHg | 133.5 (110 to 157) | 118 (88 to 150) | 124.2 (88 to 157) |
| Baseline Diastolic Blood Pressure | mmHg | 85 (76 to 94) | 71.3 (56 to 96) | 76.8 (56 to 96) |
| Baseline Pulse Rate | beats per minute | 81 (78 to 84) | 79 (60 to 104) | 79.8 (60 to 104) |
| Baseline Bristol Stool Scale score | score on a scale | 3.91 (2.17 to 5.64) | 1.94 (1.75 to 2.33) | 2.73 (1.75 to 5.64) |
| Baseline Respiratory Rate | breaths per minute | 14 (12 to 16) | 15.3 (12 to 20) | 14.8 (12 to 20) |
| Baseline Degree of Straining | score on a scale | 2.21 (1.91 to 2.5) | 2.06 (1.17 to 3.25) | 2.12 (1.17 to 3.25) |
6. Primary Endpoint
The registry lists the primary outcome as Numerical Rating Scale (NRS) for Pain Change From Baseline, measured over Assessed from screening/Opioid Induced Constipation (OIC) Confirmation period through study completion, approximately 6 weeks..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change from baseline in mean daily pain intensity measured with the Numerical Rating Scale. The scale ranges from 0, no pain, to 10, worst possible pain. The registry defines change as the post-baseline value minus the baseline value, with baseline based on mean daily scores during the opioid-induced constipation confirmation period. Post-baseline values were calculated as the mean of NRS scores during visits 2-4. The stated timeframe runs from screening and confirmation through study completion, approximately 6 weeks.
A change score expresses how a participant's measured outcome differs from that participant's baseline. As defined in the record, lower values are better and higher values are worse. Therefore, a positive change represents an increase in the score relative to baseline, while a negative change represents a decrease. This describes the scale's direction; it does not establish why a score changed.
Pain scores are relevant to a study enrolling people with cancer and pain, and a repeated daily measure can describe symptom levels over the specified period. The endpoint is not itself a direct measure of bowel function. The registry lists bowel-related secondary outcomes, including rescue-free bowel movements, time to first rescue-free laxation, stool scores, and constipation symptom and quality-of-life assessments. The reason this pain endpoint was selected as primary, including any formal rationale for its relationship to the study purpose, is not reported in the registry record.
The registry reports a mean change and a full range for each arm. A range describes the spread from the lowest to the highest observed value; it is not a confidence interval and does not quantify the precision of an estimated treatment effect. The registry record does not report a comparative estimate for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The placebo arm's posted mean change in daily NRS was 0.65, with a full range of 0.3 to 1.0 among 2 participants. The naloxegol arm's posted mean change was 0.33, with a full range of -0.4 to 1.4 among 3 participants. Under the registry's scoring definition, positive changes indicate higher pain scores relative to baseline, while negative changes indicate lower scores. These are separate arm-level summaries, not an adjusted or unadjusted estimate of the difference between treatments.
The ranges overlap, and each arm's range is based on very few participants. Such small summaries can be strongly affected by the individual observations included. They do not provide a stable account of the range of outcomes that might occur in a broader population. The registry does not report confidence intervals, standard errors, a p-value, or a treatment-effect estimate for the primary outcome. Consequently, the posted values do not establish the precision of a between-arm comparison or whether any apparent difference could be distinguished from random variation.
The registry reports 12 participants enrolled but provides primary outcome summaries for 2 participants in the placebo arm and 3 in the naloxegol arm. The reason for this difference is not reported in the registry record. It is not possible to determine from these summaries whether the remaining enrolled participants did not complete the study, had no usable primary outcome data, or were excluded for another reason. The counts should not be treated as the full enrollment or as a complete account of participant flow.
The study is marked terminated, but its termination reason is not reported in the registry record. The posted primary outcome values therefore need to be read as limited descriptive results rather than as a definitive comparative evaluation. The record also lists seven secondary outcomes, while complete numerical results or analysis details for those outcomes are not reported in the registry record. The listed outcomes indicate the range of measures considered, but they do not supply evidence about their observed results.
Overall, the posted primary data show modest positive mean changes in both arms, with a wider range of individual values in the naloxegol arm. This description should not be converted into a claim that one intervention caused better or worse pain outcomes. The small arm counts, absence of a reported comparative estimate, and lack of information about missing outcome data leave substantial uncertainty about both the size and reliability of any treatment contrast.
9. Statistical Methods Explained
The registry identifies a mean change from baseline as the primary outcome summary and gives a full range as the measure of dispersion. These statistics have different roles. A mean summarizes the central level of the observations in an arm. A range reports the lowest and highest observed values. Neither statistic alone gives the uncertainty around the difference between randomized groups.
What does a change score represent?
In general, a change score is calculated by subtracting a baseline measurement from a later measurement. The registry specifies the direction as post-baseline minus baseline. For this endpoint, baseline is the mean daily NRS during the opioid-induced constipation confirmation period, and the post-baseline measure is the mean of NRS scores during visits 2-4. A positive change means the measured score is higher than baseline; a negative change means it is lower. The clinical meaning of the direction depends on the scale, and the registry explicitly states that lower pain scores are better.
Change scores can be useful because they place follow-up measurements in relation to each participant's starting level. However, an arm-level mean change does not reveal the full pattern of individual responses, and a range does not show how likely values near either endpoint are. With very few observations, a single participant's value can have substantial influence on the mean and the reported range. This is a general statistical concern, not a finding about unreported participant-level data.
How should the ranges be read?
A full range extends from the minimum to the maximum observed value. For placebo, the posted range is 0.3 to 1.0; for naloxegol, it is -0.4 to 1.4. These ranges describe the observed values in the respective groups. They are not confidence intervals, do not express the precision of the group means, and do not estimate the range of outcomes in all eligible patients. A confidence interval, in general, is an interval constructed to express statistical uncertainty about an estimated quantity under specified assumptions. No confidence interval for the primary treatment contrast is reported in the registry record.
What is missing from a comparative analysis?
Randomization is intended, in general, to support a fair comparison by assigning participants to treatment groups without choosing assignment according to their measured characteristics. But an interpretation of results still requires a clearly defined treatment-effect estimate and information about its uncertainty. The registry posts the mean change and range separately for each arm, but does not report a numerical difference between arms, a model-based contrast, or an inferential test for this outcome. The record lists zero analysis records. It does not report whether an analysis plan specified covariate adjustment, repeated-measures modeling, or another approach.
A comparative estimate would ordinarily be accompanied by a measure of uncertainty, such as a confidence interval, and possibly a test result. Those details help distinguish the estimated magnitude from the uncertainty around it. Without them, the arm summaries can be described, but the precision and statistical evidence for a treatment contrast cannot be assessed from the registry record. No new contrast should be calculated from the displayed arm summaries as a substitute for the sponsor's planned analysis.
Why does the outcome count matter?
The registry reports enrollment of 12, whereas the primary endpoint summaries show 2 participants for placebo and 3 for naloxegol. In general, unequal or incomplete availability of outcome measurements can affect interpretation if the participants with observed outcomes differ from those without them. The registry does not describe participant flow, reasons for missing measurements, or an approach to missing data. It is therefore not possible to assess whether the posted outcome summaries represent all randomized participants or a selected subset.
The number of participants contributing data also affects how much information the summaries contain. In general, small samples yield imprecise estimates and may not represent the variability of outcomes in a wider population. This does not establish that the posted values are inaccurate; it means they provide limited information about the population-level treatment effect. The record does not provide a sample-size justification or a detailed account of the intended analysis population.
How should planning illustrations be understood?
Sample-size planning is a forward-looking exercise: it considers how many participants might be needed under stated assumptions to detect a chosen effect with a specified statistical approach. The registry's planning description refers to a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are planning illustrations, not evidence that a study had a given probability of finding a result. They are not observed power and do not resolve the limitations of the small posted outcome counts. Numeric planning estimates are not reported in the registry record.
In general, assumptions used for planning may not match the true effect or variability in a completed study. A planning calculation based on an observed effect is especially dependent on that estimated effect, which can be unstable when the observed data are sparse. The registry does not report the trial's own sample-size rationale, so the planning description should not be read as the original design justification.
Finally, the record lists a two-week randomized, double-blind period and a two-week open-label period, while the primary outcome timeframe is described as approximately 6 weeks. Those design features define the context for measurement, but detailed timing and analysis rules are not reported. No particular model or distributional assumption beyond the planning description can be attributed to the primary analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven secondary outcomes, including rescue-free bowel movement response, time to first post-dose rescue-free laxation, Bristol Stool Scale score, constipation symptom and quality-of-life assessments, straining, and complete evacuation. It also lists 16 outcome measures in total. The record does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment for testing several outcomes. When multiple outcomes are examined, general statistical practice recognizes that the chance of at least one apparently notable result can increase; without a stated plan, the interpretation of multiple tests would be uncertain. The posted record does not supply analysis results for the listed secondary outcomes.
Missing-data methods and analysis populations are not reported in the registry record. Although enrollment is listed as 12, the primary endpoint summaries include 2 placebo participants and 3 naloxegol participants. The record does not give a participant flow account, explain the smaller outcome counts, or state whether analyses used all randomized participants, only participants with observed measurements, or another population. It also does not describe any imputation or sensitivity analysis for missing outcomes.
The status is terminated, but the reason is not reported in the registry record. No interim analysis plan, stopping rule, or detailed statistical analysis plan is reported. These absences mean that the reader cannot assess whether outcome selection, missingness, or analytic decisions were governed by prespecified procedures. They do not establish that such procedures were absent; their details are simply not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 0 | 2 | 0.0% |
| Naloxegol | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 2 |
| Naloxegol | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 2 of 2 |
| Naloxegol | 3 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Naloxegol |
|---|---|---|---|
| diarrhea | Gastrointestinal disorders | 2 of 2 | 0 of 3 |
| Nausea | Gastrointestinal disorders | 1 of 2 | 0 of 3 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | 1 of 2 | 0 of 3 |
| fever | General disorders | 1 of 2 | 0 of 3 |
| chills | General disorders | 1 of 2 | 0 of 3 |
| abdominal distention | General disorders | 1 of 2 | 0 of 3 |
| bladder spasms | Renal and urinary disorders | 0 of 2 | 1 of 3 |
| increased back pain | Musculoskeletal and connective tissue disorders | 0 of 2 | 1 of 3 |
| increased abdominal pain | General disorders | 0 of 2 | 1 of 3 |
| worsening constipation | Gastrointestinal disorders | 0 of 2 | 1 of 3 |
The serious adverse event figures are reported by arm. In the placebo arm, 0 serious adverse events were reported among 2 participants at risk. In the naloxegol arm, 0 were reported among 3 participants at risk. The registry also reports 0 deaths in each arm. These are counts from the posted safety record and should be read alongside the small numbers of participants represented.
The record reports other adverse events for 2 participants at risk in the placebo arm and 3 in the naloxegol arm. The counts affected are 2 and 3, respectively. These figures indicate that at least one other adverse event was recorded for each participant represented in those arm-level counts; the registry does not provide the specific event terms in the information. The serious-event term list is empty.
These counts do not establish whether events were caused by the assigned treatment. They also do not support a reliable comparison of safety between arms, given the small numbers. A count of zero serious events in these summaries is not proof that serious events cannot occur. The registry record does not report event timing, severity details beyond the serious/non-serious categorization, or further information needed to characterize individual events.
12. What the Result Does, and Does Not, Mean
The posted primary outcome results describe mean change in daily pain scores among a small number of participants in each arm. Both arm means are positive, and the scale definition identifies a positive change as an increase from baseline. The summaries also show the observed full range in each arm. These registry entries describe the posted measurements; they do not identify the cause of change or quantify a reliable treatment contrast.
The record does not report a comparative estimate, confidence interval, or p-value for the primary outcome. It is therefore not possible to infer the magnitude or precision of a between-arm effect from a formal analysis in the registry record. The arm-level means should not be treated as proof that naloxegol improved or worsened pain relative to placebo. Nor does the absence of a reported inferential result establish that the treatments were equivalent.
The study's stated purpose concerns tolerability, safety, and feasibility for naloxegol in patients with cancer and opioid-induced constipation. The primary endpoint is pain change, while the listed secondary outcomes cover constipation and bowel function. Numerical results for those secondary outcomes are not reported in the registry record. As a result, the posted primary endpoint summaries do not answer whether the intervention changed bowel outcomes, and the available safety counts are too limited to characterize uncommon events.
The registry reports enrollment of 12, but the primary endpoint summaries include 2 participants in the placebo arm and 3 in the naloxegol arm. The explanation is not reported in the registry record. Together with the terminated status and the lack of reported analysis details, this leaves uncertainty about how representative the posted outcome summaries are of the enrolled or randomized participants.
The appropriate reading is therefore narrow: these are descriptive arm-level pain-score changes from a small set of participants in a terminated trial, accompanied by limited safety counts. They are not a complete comparative evaluation of efficacy, constipation outcomes, or safety. Further conclusions would require information not reported in the registry record, including participant flow, analysis methods, missing-data handling, and results for the listed secondary endpoints.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its design and its posted results answer different levels of question. Randomization can support a comparison between assigned groups, but the reported primary results are separate arm summaries rather than a treatment-effect estimate. Without a contrast and its uncertainty, the reader can describe the observed means and ranges but cannot judge the precision of a comparative result from the registry record.
The difference between enrollment and the primary outcome counts is also important. The registry lists 12 enrolled participants, while the arm summaries include 2 and 3 participants. In clinical research, the number enrolled, the number randomized, and the number contributing to a particular outcome may differ. Participant flow and reasons for missing outcome data are needed to understand those differences and assess potential bias. They are not reported in the registry record.
The example also shows why endpoint alignment matters. The stated study purpose focuses on naloxegol's tolerability, safety, and feasibility for opioid-induced constipation, while the primary outcome is pain-score change. Bowel-function measures appear among the secondary outcomes, but their numerical results are not reported in the registry record. A trial's headline purpose should not be substituted for the outcome actually summarized.
Finally, absence of reported inferential results is not the same as evidence of no difference. It is a limit on what can be concluded from the record. Small outcome counts, a terminated status with no reported reason, and missing analysis details all call for restraint. The trial is useful as an example of how to separate descriptive data from a comparative claim and how registry transparency affects statistical interpretation.
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 primary outcome summaries are based on 2 participants in the placebo arm and 3 in the naloxegol arm, despite registry enrollment of 12. The registry does not explain this difference or report which participants contributed data. Without participant flow, it is not possible to determine the extent or reasons for incomplete outcome data, or whether the posted summaries represent a selected subset.
The record provides means and full ranges but no comparative estimate, confidence interval, p-value, or detailed analysis description for the primary endpoint. The reported ranges do not quantify uncertainty in the arm means or in a treatment contrast. The record does not identify a planned model, analysis population, missing-data method, or sensitivity analysis.
The trial is marked terminated, but its termination reason is not reported in the registry record. The record does not report the protocol, sample-size justification, interim analyses, or detailed statistical plan. Those absences prevent assessment of whether the study stopped as planned, whether outcome analyses followed prespecified methods, or how enrollment was intended to support the primary comparison.
Although seven secondary outcomes are listed, their numerical results are not reported in the registry record. No multiplicity approach is described. The primary endpoint measures pain-score change, not bowel function directly, so it does not by itself address all aspects of the study's stated purpose. Finally, safety counts are limited to a small number of participants, and event terms and further clinical details are not reported. These limitations constrain both comparative interpretation and generalization beyond the participants represented in the posted summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) — NCT02839889.
- Registry record last updated 2019-03-05; status last verified 2019-02.
- Results first posted 2019-03-05.
- 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.
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18. Record Summary
The registry record describes NCT02839889, a phase 4 randomized parallel study of naloxegol and placebo in patients with cancer and opioid-induced constipation. The study was quadruple-masked, had enrollment of 12, and is marked terminated. The study description includes a two-week randomized double-blind period followed by a two-week open-label period.
The primary endpoint was change from baseline in mean daily NRS pain scores, assessed through study completion, approximately 6 weeks. Posted summaries include 2 placebo participants and 3 naloxegol participants. Their mean changes were 0.65 and 0.33, respectively, with full ranges of 0.3 to 1.0 and -0.4 to 1.4. The record does not report a comparative estimate or the reason for the smaller outcome counts.
The registry lists seven secondary outcomes and 16 outcome measures in total. It reports no serious adverse events or deaths in either arm, alongside other adverse events affecting 2 placebo participants and 3 naloxegol participants. The termination reason, detailed analysis plan, and secondary outcome results are not reported in the registry record.