Comparison · NCT04507204-sae
Adhansia XR vs Concerta: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Adhansia XR vs Concerta: serious adverse events. Trial comparisons, record NCT04507204-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04507204-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0226 | 0.0077 | 0.0642 | wilson | |
| Risk in group 2 | 0.0299 | 0.0117 | 0.0742 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00729 | -0.0541 | 0.0382 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.756 | 0.172 | 3.31 | log | |
| Odds ratio, group 1 over group 2 | 0.75 | 0.165 | 3.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Adhansia XR than on Concerta | 137 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Adhansia XR | Methylphenidate extended-release capsules taken once daily. | 3 | 133 | EG000 |
| Group 2 | Concerta | Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food. | 4 | 134 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events were reported starting from the time informed consent for study participation up to 6 months.
Source ClinicalTrials.gov
Trial
- Title
- Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT04507204
- Phases
- PHASE4
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Adhansia XR, Concerta
- Lead sponsor
- Purdue Pharma LP
- Results first posted
- 2023-07-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04507204?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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