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 Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children (NCT04987762), a na phase 4 study. The primary outcome is The Number of Participants With Adverse Events as a Measure of Safety.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04987762 |
| Phase | Phase 4 |
| Condition | Attention Deficit/Hyperactivity Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 103 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Purdue Pharma LP |
| Results posted | Yes |
2. Clinical Question
Population
Children 4 to 12 years of age with attention deficit/hyperactivity disorder were the intended study population. The registry record describes a safety analysis population as participants who received at least 1 dose of study drug and had any safety information. The study purpose also included characterizing pharmacokinetics in 4 to 5 year-olds. Further eligibility criteria and the number of enrolled participants in each age group are not reported in the registry record.
Intervention
Participants received Adhansia XR extended-release capsules orally once daily in the morning. This was a multiple-dose study, and the stated purpose was to assess long-term safety and tolerability. Dose levels, dose adjustments, and treatment adherence details are not reported in the registry record.
Comparator
There was no comparator group. The registry record describes a single-group study with no masking and no randomized allocation. Consequently, the posted adverse-event counts describe participants who received Adhansia XR; they do not provide a like-for-like comparison with a control group.
Primary question
The primary endpoint asks how many participants experienced adverse events during the stated safety observation period, up to 9 months. Adverse events were documented from informed consent or assent through 7 days after the last study-drug administration. Events ongoing at the last study visit were followed until resolution or for 30 days after study-drug administration. The endpoint is a count of participants with events, not a measure of comparative risk or treatment effect.
3. Trial Design
The registry record identifies NCT04987762 as a Phase 4, open-label, multicenter, multiple-dose, single-group study of Adhansia XR extended-release capsules in children. The official title specifies children 4 to 12 years of age. The condition listed is attention deficit/hyperactivity disorder. Purdue Pharma LP is named as the sponsor.
Allocation is listed as not applicable, masking as none, and the model as single group. Participants took Adhansia XR orally once daily in the morning. Because there was no comparator group, the design does not support a randomized, within-trial comparison of adverse-event experience between treatments. The posted results therefore describe safety observations in the Adhansia XR group without a control-group context.
The registry record lists enrollment as 103. The study start date is 2021-08-03, and the primary completion date is 2022-04-27. Its status is terminated. The record does not report the reason for termination or how termination affected follow-up and data collection. The primary endpoint timeframe is up to 9 months, but the actual duration of exposure and follow-up for individual participants is not reported in the registry record.
The stated purpose included assessing long-term safety and characterizing pharmacokinetics in 4 to 5 year-olds. The primary endpoint reported in the results concerns adverse events; pharmacokinetic results are not listed among the posted results. Details such as the number of study sites, dose schedule, and recruitment process 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
| Stage | Adhansia XR |
|---|---|
| STARTED | 103 |
| COMPLETED | 0 |
| NOT COMPLETED | 103 |
Reasons for not completing this period:
| Reason | Adhansia XR |
|---|---|
| Study was Terminated by Sponsor | 103 |
Analysis population for the primary outcome, as defined in the registry: The safety analysis population is defined as all subjects who were administered at least 1 dose of study drug and had any safety information.
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 | Adhansia XR |
|---|---|---|
| Participants analysed | 103 | |
| Age, Continuous | years | 9 (SD 2.2) |
| Sex: Female, Male: Female | Participants | 42 |
| Sex: Female, Male: Male | Participants | 61 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 37 |
| Race (NIH/OMB): White | Participants | 60 |
| Race (NIH/OMB): More than one race | Participants | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as The Number of Participants With Adverse Events as a Measure of Safety, measured over Up to 9 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events as a measure of safety. It is a participant count: each participant is classified according to whether an adverse event was reported during the observation period. The endpoint timeframe is up to 9 months. The record says events were collected from informed consent or assent through 7 days after the last study-drug administration. Events still ongoing at the last study visit were followed until resolution or for 30 days after study-drug administration.
As a general statistical point, counting participants with at least one event can give a straightforward summary of how many people experienced an event. It does not describe the total number of event episodes, their duration, or their severity unless those details are separately reported. Nor does a count from a single-group study estimate a comparative difference between treatment groups.
The registry record defines the safety analysis population as participants who received at least 1 dose and had any safety information. The posted adverse-event group lists 103 participants at risk. The record does not report additional endpoint definitions, such as how recurrent events were handled, or an analysis method for the endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results report 2 participants in the Adhansia XR group in the serious adverse-event category and 39 participants in the other adverse-event category. The group lists 103 participants at risk. The record also lists 0 deaths. These are descriptive counts from a single group, not estimates from a randomized comparison.
The serious adverse-event terms listed are Suicidal Ideation, 1.0%, and Constipation, 1.0%. The registry record does not provide additional details about these events, such as timing, duration, outcome, or participant-level overlap between event categories. The percentages should be read as posted; they do not establish whether a term occurred in a participant who also experienced another listed event.
The outcome is a count of participants with reported events, with an observation period extending up to 9 months. Participants may have had different lengths of exposure or observation, but those durations are not reported in the registry record. Without individual follow-up details, the counts do not describe event rates per unit of time. Without a comparator group, they also cannot separate events associated with study participation from events that might have occurred for other reasons.
The registry record lists one outcome measure and zero analyses. It does not report an inferential analysis, confidence interval, hypothesis test, or adjusted estimate for the primary endpoint. Thus, the posted information supports a descriptive account of the recorded event counts, but does not quantify statistical precision around those counts. It also does not establish comparative safety or answer an efficacy question.
The study status is terminated, and the reason for termination is not reported in the registry record. That status alone does not explain whether the planned observation period was completed for all participants or whether the results reflect all collected safety information. The record does not report such details. Interpretation should therefore remain tied to the counts and descriptions that are explicitly posted.
9. Statistical Methods Explained
What kind of outcome is reported? The primary measure is binary at the participant level: a participant either had an adverse event recorded during the defined observation period or did not. The results describe the number of participants with events. As a general statistical concept, a binary outcome reduces a participant’s experience to a category, so it does not preserve information about the number of separate episodes, the time events began, or their duration unless those features are reported separately. The registry record does not list an analysis method for this endpoint.
What does the count represent? The endpoint title refers to the number of participants with adverse events, and the safety analysis population is defined as participants who received at least 1 dose and had any safety information. The Adhansia XR results list 103 participants at risk. A count of participants with events is a descriptive summary for the group. It is not a comparison against an untreated group or another treatment, because this was a single-group study.
Why does follow-up matter? The endpoint timeframe is up to 9 months. Events were documented from informed consent or assent through 7 days after the last administration. Events ongoing at the last study visit were followed until resolution or for 30 days after administration. As a general statistical point, participants observed for different lengths of time may have different opportunities for an event to be detected. The registry record does not report individual follow-up durations, exposure time, or an event-rate analysis, so the posted counts should not be interpreted as rates adjusted for time at risk.
What would a confidence interval add? In general, a confidence interval describes the uncertainty around an estimate under a specified statistical model. For a participant count or proportion, it can indicate how compatible a range of underlying values is with the observed data and the chosen method. The registry record does not post a confidence interval or describe a method for calculating one. No interval can be inferred from the posted results without adding an analysis that is not reported in the registry record.
What does the design permit? The study is open-label and single-group, with no masking and no randomized allocation. General statistical interpretation of a single-group safety study is descriptive: it can report events observed among participants receiving the study drug, but it does not estimate a randomized between-group contrast. Open-label ascertainment can also differ from blinded ascertainment as a general consideration, but the record does not describe how event assessment was conducted beyond documenting and reporting adverse events.
Why can event categories require care? A participant may experience more than one event, and an event may be described at different levels of detail. This is a general feature of adverse-event summaries. The record lists serious adverse-event participants, other adverse-event participants, and selected serious-event terms, but does not explain overlap among categories or provide a complete event-level listing. The listed categories therefore should not be added together or treated as mutually exclusive unless the record specifies that interpretation; it does not.
What analysis details are absent? The registry record lists zero analyses. It does not report a statistical analysis plan, a hypothesis test, an adjusted estimate, a confidence interval, or an approach to missing outcome data. It also does not state whether any interim analyses were conducted or give a sample-size justification. These details are not reported in the registry record, so the posted counts should not be described as products of a particular inferential method.
How should the study status affect reading? The record status is terminated. In general, termination can be relevant to understanding whether follow-up and data collection ended as planned, but the status label alone does not identify what happened. The reason for termination, the extent of completion, and any consequences for the analysis are not reported in the registry record. The results should therefore be interpreted as the posted descriptive safety information, without assuming that all participants completed the same follow-up or that termination had a particular effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and zero analyses. It does not report a statistical analysis plan, a hierarchy of endpoints, or any adjustment for multiple testing. Because no inferential analyses are listed, there is no reported multiplicity procedure to interpret. Whether additional analyses were planned or conducted is not reported in the registry record.
The safety analysis population is defined as participants who received at least 1 dose of study drug and had any safety information. The Adhansia XR results list 103 participants at risk. The record does not report how many participants were excluded from this population, whether all enrolled participants contributed safety information, or how missing safety observations were handled. It also does not describe imputation, censoring, or sensitivity analyses for missing data.
As a general statistical consideration, missing safety information can limit how fully event counts represent the experience of all enrolled participants. The extent of that limitation depends on the amount and pattern of missing information; neither is reported in the registry record. Similarly, a single-group count does not provide a controlled estimate of comparative safety. No assumptions about missingness, multiplicity, or unreported analyses should be attached to the posted counts.
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 |
|---|---|---|---|
| Adhansia XR | 2 | 103 | 1.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adhansia XR | 0 of 103 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Adhansia XR | 39 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | Adhansia XR |
|---|---|---|
| Suicidal Ideation | Psychiatric disorders | 1 of 103 |
| Constipation | Gastrointestinal disorders | 1 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Adhansia XR |
|---|---|---|
| Insomnia | Psychiatric disorders | 18 of 103 |
| Decreased appetite | Metabolism and nutrition disorders | 17 of 103 |
| Irritability | Psychiatric disorders | 11 of 103 |
| Abdominal pain upper | Gastrointestinal disorders | 10 of 103 |
| Upper respiratory tract infection | Infections and infestations | 8 of 103 |
Serious events with the highest arm-level rate: suicidal ideation (1.0%), constipation (1.0%).
The serious adverse-event results list 2 participants in the Adhansia XR group, with 103 participants at risk. The listed serious-event terms are Suicidal Ideation, 1.0%, and Constipation, 1.0%. The record lists 0 deaths. These figures describe what was recorded in this study group; they are not a comparison with a control group.
The record does not provide event narratives, timing, duration, outcomes, or information about whether the same participant experienced more than one serious event or term. It also does not report the number of event episodes separately from the number of participants affected. The percentages are registry-posted values and should not be used to infer additional details beyond the information explicitly listed.
As a general point, an adverse event recorded during a study is not, by itself, evidence that the study drug caused it. The registry record does not report a causal assessment for the listed events. The single-group design and the absence of a comparator further limit interpretation of the counts as comparative safety evidence.
12. What the Result Does, and Does Not, Mean
The posted results describe adverse events recorded among participants who received Adhansia XR in an open-label, single-group study. They report 2 participants in the serious adverse-event category, 39 participants in the other adverse-event category, and 0 deaths. The selected serious-event terms are Suicidal Ideation and Constipation, each listed as 1.0%. The group lists 103 participants at risk.
These counts do not show how the results compare with another treatment, because the study had no comparator group. They do not establish whether an individual event was caused by Adhansia XR, and they do not quantify comparative risk. The registry record does not post confidence intervals or inferential analyses for the primary endpoint, so the statistical precision of the counts is not quantified in the record.
The information also does not describe the full clinical context of each event, including timing, duration, outcome, or overlap among event categories. The up-to-9-month timeframe is a study endpoint timeframe, not evidence that every participant had the same exposure or follow-up duration. Details about individual follow-up are not reported in the registry record.
The stated study purpose included long-term safety and pharmacokinetics in 4 to 5 year-olds. The posted results concern adverse events; pharmacokinetic results are not reported in the registry record. The record does not report enough detail to draw conclusions beyond the descriptive safety counts and the specific event terms it lists.
13. Why This Trial Matters Statistically
Safety studies often summarize whether participants experienced adverse events, making the participant count a readily interpretable descriptive outcome. In this study, the registry record defines the safety population by study-drug exposure and availability of safety information, and the results list participants at risk alongside event counts. These details help clarify what the reported counts are intended to describe.
The design is also important for statistical interpretation. This was an open-label, single-group study without randomized allocation or a control group. As a general statistical principle, a single-group summary can characterize events observed during study participation, but it cannot provide a randomized contrast or distinguish the contribution of treatment from other explanations. Recognizing that distinction prevents descriptive counts from being mistaken for a comparative treatment estimate.
The stated purpose included both long-term safety assessment and pharmacokinetic characterization in 4 to 5 year-olds, while the posted endpoint results concern adverse events. Keeping those questions distinct is statistically important: a safety count does not answer a pharmacokinetic question, and a stated purpose does not establish that results for each objective are available. Pharmacokinetic results are not reported in the registry record.
The record also lists zero analyses and does not report inferential methods, missing-data handling, or the reason the study was terminated. Those omissions matter because they limit assessment of precision, completeness, and the relationship between the posted counts and any planned analysis. The results are most appropriately read as descriptive information, with the design and reporting limits kept in view.
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 single-group design has no concurrent comparator, so the posted event counts cannot estimate a randomized difference between treatments. The study is also open-label, and the registry record does not describe blinded event assessment. The results therefore provide a descriptive record of events observed among participants receiving Adhansia XR, rather than a controlled comparison.
The registry record lists the study as terminated but does not report the reason for termination or explain whether it affected follow-up, enrollment, or data collection. Although the primary endpoint timeframe is up to 9 months, individual exposure and follow-up durations are not reported. The completeness of follow-up cannot be assessed from the listed information.
There is no reported statistical analysis plan, confidence interval, hypothesis test, or adjusted estimate. The record lists zero analyses and does not state how missing safety information was handled. It does not provide detailed event narratives, timing, duration, outcomes, or overlap among event categories. The listed serious-event terms therefore have limited context in the registry record.
The intended population is children 4 to 12 years of age, and the study purpose included pharmacokinetic characterization in 4 to 5 year-olds. Age-specific enrollment and results are not reported. Pharmacokinetic findings are also not reported in the registry record. These limitations constrain how specifically the posted safety counts can be interpreted across age groups or study objectives.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children — NCT04987762.
- Registry record last updated 2023-08-22; status last verified 2023-07.
- Results first posted 2023-08-22.
- 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
NCT04987762 is a Phase 4, open-label, multicenter, multiple-dose, single-group study of Adhansia XR extended-release capsules in children with attention deficit/hyperactivity disorder. The official title specifies ages 4 to 12 years, and the stated purpose includes long-term safety assessment and pharmacokinetic characterization in 4 to 5 year-olds. Participants took the capsules orally once daily in the morning.
The registry record lists enrollment of 103, a study start date of 2021-08-03, a primary completion date of 2022-04-27, and a terminated status. The primary endpoint is the number of participants with adverse events over up to 9 months. Results list 2 participants in the serious adverse-event category, 39 in the other adverse-event category, and 0 deaths; selected serious-event terms are each listed as 1.0%.
No comparator group was used. The record lists one outcome measure and zero analyses. The reason for termination, inferential analysis details, missing-data methods, and pharmacokinetic results are not reported in the registry record.