Comparison · NCT04117178-sae
Intervention Arm vs Standard of Care: 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. Intervention Arm vs Standard of Care: serious adverse events. Trial comparisons, record NCT04117178-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04117178-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 | 0.104 | 0.0515 | 0.2 | wilson | |
| Risk in group 2 | 0.0923 | 0.043 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0122 | -0.0964 | 0.12 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.402 | 3.19 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.364 | 3.62 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intervention Arm than on Standard of Care | 82.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Arm | Participants allocated to this arm follow are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention arm not experiencing side effects will have their treatment adjusted after 6 months based upon serum level of the drug in question.~Donepezil: Adjustment of treatment with donepezil according to serum level.~Memantine: Adjustment of treatment with memantine according to serum level.~Measurement of serum level of anti-dementia drug: Participants allocated to the intervention arm are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention group not experiencing side effects will have their treatment adjusted after 6 months based upon serum levels of the drug in question.~Participants allocated to the standard of care arm follow the usual routines of the dementia clinic but are requested to have the serum level of the prescribed drug and CYP2D6-genotype measured after 12 month. | 7 | 67 | EG001 |
| Group 2 | Standard of Care | Participants allocated to this arm follow the usual routines of the out patient dementia clinic but are requested to have the serum level of the prescribed drug measured after 12 month. Also, CYP2D6, BcHE K and APOe4 status will be determined after 12 months.~Measurement of serum level of anti-dementia drug: Participants allocated to the intervention arm are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention group not experiencing side effects will have their treatment adjusted after 6 months based upon serum levels of the drug in question.~Participants allocated to the standard of care arm follow the usual routines of the dementia clinic but are requested to have the serum level of the prescribed drug and CYP2D6-genotype measured after 12 month. | 6 | 65 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Source ClinicalTrials.gov
Trial
- Title
- Monitoring Anti-Dementia Drugs by Serum Levels
- NCT number
- NCT04117178
- Phases
- PHASE4
- Conditions
- Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease, Dementia Alzheimers, Alzheimer Disease
- Interventions
- Donepezil, Memantine, Measurement of serum level of anti-dementia drug
- Lead sponsor
- Zealand University Hospital
- Results first posted
- 2025-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04117178?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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