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 Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA (NCT00434213), a na phase 4 study. The primary outcome is Dermal Reactions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00434213 |
| Phase | Phase 4 |
| Condition | Attention Deficit Hyperactivity Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 309 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Noven Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Pediatric patients aged 6–12 with attention deficit/hyperactivity disorder (ADHD). The registry lists an enrollment of 309 and identifies the primary-outcome population as the safety population.
Intervention
DAYTRANA, also described as methylphenidate transdermal system (MTS). The study was designed to characterize dermal reactions associated with its use.
Comparator
No comparator group is listed. The registry describes a single-group, open-label study, so the design does not provide a like-for-like control comparison.
Primary question
What dermal reactions were observed during the stated seven-week timeframe, with findings graded for erythema, edema, papules, and vesicles?
The clinical question is descriptive: it concerns the pattern of dermal findings during DAYTRANA use in the enrolled pediatric study population. It is not a randomized comparison of DAYTRANA with another treatment or with a control condition. The registry also lists contact sensitization to methylphenidate as a secondary outcome, but does not report its result.
The primary outcome description specifies a grading scale from 0, meaning no irritation, to 7, meaning strong reaction. That scale concerns observed skin findings; the record does not provide numerical results by finding, score, or participant. Accordingly, the clinical question can be identified from the registry, but the magnitude and distribution of the recorded reactions cannot be assessed from the posted results.
3. Trial Design
The registry identifies this as a Phase IV, multicenter, open-label study of DAYTRANA in pediatric patients aged 6–12 with ADHD. Its stated purpose was to characterize dermal reactions. The brief summary says study visits would occur over approximately 14 weeks, while the primary outcome has a seven-week timeframe. These are separate descriptions in the record; it does not explain their relationship.
The study is listed as completed, with an enrollment of 309. It is classified as a single-group study, and allocation is listed as not applicable. No masking was used. These features matter for interpretation: the study can describe observed findings among participants who received the intervention, but the design does not support a controlled estimate of how those findings compare with a different treatment or with no treatment.
The primary outcome is titled “Dermal Reactions,” is measured in participants, and is identified as a number outcome. Its description says dermal reactions were graded on a scale ranging from 0 for no irritation to 7 for strong reaction, based on observed erythema, edema, papules, and vesicles. The safety population is named as the primary-outcome population. The registry also lists contact sensitization to methylphenidate as a secondary outcome.
The record does not report detailed eligibility criteria, the treatment regimen, rules for assigning or summarizing skin grades, or a statistical analysis plan. It also does not report a numerical primary-outcome result or an analysis for that outcome. The enrollment figure therefore should not be mistaken for a count of participants with a reported primary-outcome result.
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 | Daytrana |
|---|---|
| STARTED | 309 |
| COMPLETED | 260 |
| NOT COMPLETED | 49 |
Reasons for not completing this period:
| Reason | Daytrana |
|---|---|
| Adverse Event | 12 |
| Lack of Efficacy | 9 |
| Lost to Follow-up | 14 |
| Withdrawal by Subject | 7 |
| Protocol Violation | 3 |
| Unable to comply with study visit window | 2 |
| Application site reaction | 1 |
| Non-compliant to study schedule | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety population
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 | Daytrana |
|---|---|---|
| Participants analysed | 309 | |
| Age, Categorical: <=18 years | Participants | 309 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 9.1 (SD 1.95) |
| Sex: Female, Male: Female | Participants | 91 |
| Sex: Female, Male: Male | Participants | 218 |
| Region of Enrollment: United States | participants | 309 |
6. Primary Endpoint
The registry lists the primary outcome as Dermal Reactions, measured over 7 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is “Dermal Reactions,” described as a count of participants and assessed over a seven-week timeframe. The record says reactions were graded from 0, indicating no irritation, to 7, indicating a strong reaction. The observed findings named in the description are erythema, edema, papules, and vesicles.
A graded assessment can describe more than whether a reaction was simply present or absent: it can represent the observed intensity of a finding along an ordered scale. In general, recording several types of visible skin findings can help characterize the nature of a dermal response rather than relying on a broad, undifferentiated event label. That is the rationale for this kind of endpoint; it does not establish what was observed in this study.
The registry does not explain whether grades were recorded separately for each finding, combined into a participant-level summary, or reduced to a threshold for the reported number. Nor does it give the actual distribution of grades, the number of participants meeting any reaction definition, or an uncertainty estimate for the primary endpoint. Although the outcome is described as a participant count, its numerical result is not reported in the registry record. The endpoint’s measurement description can therefore be interpreted, but the observed level of dermal reaction cannot be quantified from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry gives the purpose and measurement approach for the primary endpoint, but it does not give a numerical result for dermal reactions. It is therefore not possible to describe the frequency or severity of the primary endpoint from the posted results. In particular, the scale description does not tell readers which grades were observed, how the findings were distributed, or how many participants had a reaction under any specified definition.
The adverse-event information does include counts for the Daytrana group. The record lists 305 participants at risk for serious adverse events and 0 affected, and 305 at risk for other adverse events and 242 affected. These are separate event categories in the registry. The record does not provide a detailed explanation of how the categories relate, so they should not be treated as mutually exclusive or added together.
The enrollment figure is 309, while the adverse-event entries use 305 as the number at risk. The registry does not explain this difference. It should not be interpreted as evidence about withdrawals, missing data, or exclusions without further information. The primary outcome identifies the safety population, but the record does not provide a participant flow or a detailed definition of that population.
No analysis is listed for the primary or secondary outcomes. The record reports no effect estimate, confidence interval, hypothesis test, or p-value for dermal reactions or contact sensitization. Without such results, the precision of an estimated primary-outcome frequency cannot be evaluated. The absence of a numerical result is not evidence that no dermal reactions occurred; it means the registry record does not state the primary result.
Because the design has one open-label group and no listed comparator, any observed events would be descriptive of the study participants during the observation period. They would not, by themselves, establish whether the intervention caused an event or how event occurrence compares with another treatment. The registry also does not report sufficient outcome data to make a descriptive estimate for the primary endpoint.
9. Statistical Methods Explained
Statistical interpretation depends first on what the outcome represents and how it was reported. Here, the primary endpoint is described as a participant count, while the clinical observations were graded on a scale from 0 for no irritation to 7 for a strong reaction. A count answers a different question from a distribution of grades: the count can indicate how many participants meet a specified event definition, while the grade distribution describes the recorded intensity. The registry does not state how the grades were converted into the listed number outcome, and it does not report that number.
What can a participant count tell the reader?
A participant count is a descriptive summary. To interpret it fully, readers need the event definition, the population included in the calculation, and the number of participants assessed. A denominator helps place a count in context, but a count alone does not show uncertainty around an underlying event frequency. In this record, the safety population is named, but the primary result and its denominator are not reported. The adverse-event entries do include at-risk counts, which allow those entries to be read as counts among the stated at-risk groups. No new percentage or rate is needed to describe the posted figures.
Why does a single-group design matter?
In a single-group study, observations describe what occurred among participants receiving the intervention under study. A control group can help distinguish outcomes associated with an intervention from outcomes that might also occur without it or under another treatment. Without such a comparison, a descriptive event count cannot isolate the intervention’s contribution. Open-label status also means masking was not used, as the registry states; the record does not describe procedures to limit possible effects of knowledge of treatment on assessment.
What do uncertainty measures usually add?
In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. It is not a guarantee that the true value lies within its limits, and its width is informative about precision. A p-value, when reported, addresses compatibility of data with a specified statistical model or null hypothesis; it does not measure clinical importance or establish causation. Neither a confidence interval nor a p-value for the primary endpoint is reported in the registry record. The missing result prevents readers from judging its precision or evaluating an inferential claim.
What does the planning illustration represent?
The stated sample-size approach is a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers detecting a stated fraction of the observed effect. Such calculations describe hypothetical planning under those assumptions; they are not the original study’s design justification and are not observed power. The registry classifies this trial as a single-group study, so a hypothetical two-arm planning comparison should not be mistaken for a comparison that took place in this trial. Numerical planning results are not reported in the registry record.
In general, over-dispersion matters when count outcomes vary more than a statistical model assumes: standard errors can then be understated and intervals too narrow if the model does not accommodate that variability. No over-dispersion measure or count model is reported for this endpoint. The registry also does not report adjusted analyses, subgroup analyses, or a method for handling the graded observations. Those approaches should not be assumed to have been used.
Finally, statistical interpretation depends on the analysis population and completeness of outcome measurement. A stated safety population provides some context, but the record does not explain who was included, how missing assessments were handled, or whether all participants contributed to each outcome. These details limit what can be inferred from both the absent primary result and the posted adverse-event counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists dermal reactions as the primary outcome and contact sensitization to methylphenidate as a secondary outcome. It reports two outcome measures, but no analyses. It does not describe a hierarchy of hypotheses, a multiplicity adjustment, or a plan for interpreting several outcomes together. The record therefore does not establish whether any adjustment was intended or applied.
In general, testing multiple outcomes can increase the chance of obtaining at least one apparently notable result by chance. Multiplicity procedures can address that issue, but the suitable approach depends on the planned questions and analysis. Since the registry reports no outcome analyses or inferential results, there is no basis to assess how multiplicity was handled or whether it changed an interpretation.
Missing-data methods are also not reported. The registry names the safety population for the primary outcome and gives at-risk counts for adverse events, but it does not state how participants with unavailable skin assessments or other missing outcome information were treated. It provides no participant-flow description, reasons for missingness, or sensitivity analysis. The difference between the enrollment entry and the adverse-event at-risk entries is not explained and should not be used to infer a particular missing-data process.
In general, missingness can affect descriptive counts and estimates if the participants with unobserved outcomes differ systematically from those with recorded outcomes. A transparent analysis would state the population included for each outcome and how incomplete assessments were handled. Those details are not reported in the registry record. The record also does not report interim analyses, stopping rules, or a fuller statistical analysis plan.
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 |
|---|---|---|---|
| Daytrana | 0 | 305 | 0.0% |
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 |
|---|---|
| Daytrana | 242 of 305 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Daytrana |
|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | 95 of 305 |
| Headache | Nervous system disorders | 50 of 305 |
| Insomnia | Psychiatric disorders | 32 of 305 |
| Abdominal pain upper | Gastrointestinal disorders | 26 of 305 |
| Affect lability | Psychiatric disorders | 22 of 305 |
| Nausea | Gastrointestinal disorders | 22 of 305 |
| Upper respiratory tract infection | Infections and infestations | 20 of 305 |
| Irritability | Psychiatric disorders | 18 of 305 |
The registry lists 305 participants at risk for serious adverse events, with 0 affected. For other adverse events, it lists 305 at risk, with 242 affected. These are participant counts as represented in the registry record; they are not the primary dermal-reaction result.
The two entries should be kept separate. The record does not explain whether a participant could appear in both categories, so the counts should not be added or treated as non-overlapping groups. It also does not provide event terms for the serious category, a breakdown of other adverse events, severity details, or an explanation of the assessment and reporting rules. The absence of listed serious events does not supply those missing details.
The enrollment entry is 309, whereas each adverse-event entry gives 305 at risk. The reason is not reported in the registry record. The difference should not be assigned to withdrawal, missingness, or any other cause without documentation. These counts describe the posted safety data; without a comparator, they do not establish how the event experience differs from another treatment or from an untreated condition.
12. What the Result Does, and Does Not, Mean
The record supports a limited description of the study: it was a completed, Phase IV, multicenter, open-label, single-group study of DAYTRANA in pediatric patients aged 6–12 with ADHD, designed to characterize dermal reactions. The primary-outcome description identifies a grading scale and the skin findings assessed. The adverse-event entries report 0 participants with serious adverse events among 305 at risk, and 242 participants with other adverse events among 305 at risk.
The record does not report a numerical result for the primary dermal-reaction endpoint. It consequently does not show the observed grades, their distribution, or the count of participants meeting a defined primary-outcome criterion. Contact sensitization is named as a secondary outcome, but its result is not reported. No analyses are listed, and no confidence intervals or hypothesis tests are given for these outcomes.
These limitations mean that the posted information cannot establish the frequency or severity of the primary dermal outcome, its statistical precision, or a comparison with an alternative. The single-group, open-label design also cannot separate intervention-associated observations from outcomes that might occur in the absence of the intervention. The absence of a reported primary result should not be read as a finding of no reactions.
The safety counts are informative as registry-reported descriptive counts, but they do not establish causation, comparative risk, or the clinical importance of individual events. The reason the at-risk entries differ from the enrollment entry is not reported. Taken together, the information describes the study’s aim, design, endpoint definition, and selected adverse-event counts, while leaving the central numerical dermal-reaction result unavailable.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between defining an outcome and reporting its result. The registry gives a clinically interpretable description of the dermal assessment: a graded scale and several observed skin findings. But without the resulting counts or grade distribution, readers cannot evaluate how frequently reactions occurred or how strong the recorded reactions were. Clear outcome definitions are important, but they cannot replace outcome data.
The design also illustrates why descriptive and comparative questions should be kept separate. A single-group study can collect information about events observed during treatment, and the posted adverse-event entries give descriptive counts. A like-for-like control comparison is not listed, however, so those data cannot provide a controlled estimate of how the event experience differs under another condition. The open-label design is another feature to consider when interpreting assessments, particularly when the outcome involves observed findings.
For biostatisticians and clinical researchers, the distinction between an outcome’s measurement scale and its reported summary is also relevant. A grade can carry information about severity, while a participant count summarizes how many people meet a defined criterion. The record does not explain the transformation from the graded observations to the number outcome, or report the primary number itself. That gap limits both clinical interpretation and statistical review.
Finally, the record shows why analysis populations, missing-data rules, and complete reporting matter. It names a safety population and gives adverse-event denominators, but does not explain the difference between enrollment and the at-risk entries or describe missing-outcome handling. These are not merely technical details: they determine which observations support a result and how far that result can be generalized. Here, the available information supports cautious description, not a conclusion about comparative effects.
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 main limitation for interpreting this trial is that the registry record does not report the numerical primary-outcome result. Although dermal reactions are described using grades from 0 to 7 and several named findings, there is no reported count by grade or finding, participant-level summary, or uncertainty estimate. The primary endpoint therefore cannot be quantified from the record.
The single-group, open-label design has no listed control comparison. It cannot distinguish the observed event experience from what might have occurred under another treatment or without the intervention. The record also does not give the treatment regimen, detailed eligibility criteria, methods for scoring the skin findings, or rules for summarizing them. These omissions limit reproducibility and make it difficult to know precisely what the endpoint count would represent.
The safety information is incomplete in other ways. Serious adverse events are reported as 0 among 305 at risk, and other adverse events as 242 among 305 at risk, but event-level terms, severity information, and category overlap are not explained. The registry does not explain why the enrollment entry is 309 while the adverse-event entries use 305 at risk. Missing-data methods, participant flow, and the exact composition of the safety population are not reported.
Contact sensitization is listed as a secondary outcome, but no result is given. No analyses are listed, and the record does not describe multiplicity handling, interim analyses, or a statistical analysis plan. The stated sample-size approach is a planning illustration and does not remedy the absence of an observed primary result.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA — NCT00434213.
- Registry record last updated 2017-04-26; status last verified 2017-03.
- Results first posted 2009-03-06.
- 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 describes a completed Phase IV, multicenter, open-label, single-group study of DAYTRANA in pediatric patients aged 6–12 with ADHD. It lists an enrollment of 309 and says study visits would occur over approximately 14 weeks. The primary outcome is dermal reactions over a seven-week timeframe, assessed using a scale from 0 for no irritation to 7 for a strong reaction for erythema, edema, papules, and vesicles.
The record identifies the safety population but does not report the primary-outcome result or any outcome analyses. Contact sensitization to methylphenidate is listed as a secondary outcome without a reported result. Adverse-event entries list 0 serious events among 305 at risk and 242 participants with other adverse events among 305 at risk. The reason for the difference between the enrollment and at-risk figures is not reported in the registry record.