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Comparison · NCT00566501-sae

Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) vs Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205): serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) vs Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205): serious adverse events. Trial comparisons, record NCT00566501-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00566501-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.140.1140.171wilson
Risk in group 20.1690.1320.213wilson
Risk difference, group 1 minus group 2-0.0283-0.07950.0195newcombe hybrid score
Risk ratio, group 1 over group 20.8320.6081.14log
Odds ratio, group 1 over group 20.8050.5551.17log
Number needed to treat, for one fewer participant with a serious adverse event on Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) than on Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)
35.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).80570EG000
Group 2Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg IR in the preceding double-blind study E2020-G000-326 (NCT00478205).56332EG001

Harm

What it counts
Total, serious adverse events
Time frame
From the first dose of study drug up to 2 years 3 months

Source ClinicalTrials.gov

Trial

Title
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
NCT number
NCT00566501
Phases
PHASE3
Conditions
Alzheimer's Disease
Interventions
Donepezil
Lead sponsor
Eisai Inc.
Results first posted
2012-06-19

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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