Comparison · NCT02346201-sae
Methylphenidate vs Placebo: 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. Methylphenidate vs Placebo: serious adverse events. Trial comparisons, record NCT02346201-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02346201-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 | 0.131 | 0.0784 | 0.212 | wilson | |
| Risk in group 2 | 0.0891 | 0.0476 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0422 | -0.0469 | 0.133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.66 | 3.29 | log | |
| Odds ratio, group 1 over group 2 | 1.55 | 0.629 | 3.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Methylphenidate than on Placebo | 23.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Methylphenidate | Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), in 5 mg over-capsulated tablets, and psychosocial intervention~Methylphenidate: Two 5mg methylphenidate over-encapsulated drug taken twice a day for 6 months (total of 20 mg methylphenidate per day), and psychosocial intervention | 13 | 99 | EG000 |
| Group 2 | Placebo | Matching over-encapsulated placebo and psychosocial intervention~Placebo: Two over-encapsulated placebo taken twice a day for 6 months and psychosocial intervention | 9 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months (enrollment until study completion)
Source ClinicalTrials.gov
Trial
- Title
- Apathy in Dementia Methylphenidate Trial 2
- NCT number
- NCT02346201
- Phases
- PHASE3
- Conditions
- Apathy, Alzheimer's Disease
- Interventions
- Methylphenidate, Placebo
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Results first posted
- 2023-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02346201?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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