Comparison · NCT00478205-sae
Donepezil SR 23 mg vs Donepezil IR 10 mg: 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. Donepezil SR 23 mg vs Donepezil IR 10 mg: serious adverse events. Trial comparisons, record NCT00478205-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00478205-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 | 0.0831 | 0.0673 | 0.102 | wilson | |
| Risk in group 2 | 0.0955 | 0.0722 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0125 | -0.0463 | 0.0177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.87 | 0.614 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.858 | 0.585 | 1.26 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Donepezil SR 23 mg than on Donepezil IR 10 mg | 80.2 | 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 | Donepezil SR 23 mg | Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period. | 80 | 963 | EG000 |
| Group 2 | Donepezil IR 10 mg | Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period. | 45 | 471 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events (AEs) were recorded from the time of informed consent until after the Final Visit or Early Termination.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
- NCT number
- NCT00478205
- Phases
- PHASE3
- Conditions
- Alzheimer's Disease
- Interventions
- Aricept (donepezil SR 23 mg), Aricept (donepezil IR 10 mg)
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2013-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00478205?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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