Comparison · NCT03710642-sae
Treatment (Prazosin) vs Placebo Oral Capsule: 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. Treatment (Prazosin) vs Placebo Oral Capsule: serious adverse events. Trial comparisons, record NCT03710642-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03710642-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 | 0.192 | 0.0851 | 0.379 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0.192 | -0.149 | 0.379 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Treatment (Prazosin) than on Placebo Oral Capsule | 5.2 | 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 | Treatment (Prazosin) | Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period.~Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3~1 mg QAM and 1 mg QHS for days 4 to 7~1. mg QAM and 2 mg QHS for days 8 to 10~2. mg QAM and 2 mg QHS for days 11 to 14~Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29,~Dose increases will be allowed only during the fixed and flexible dosing periods.~Prazosin: Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules | 5 | 26 | EG000 |
| Group 2 | Placebo Oral Capsule | Placebo medication will be administered in a titration schedule mimicking the active comparator treatment.~Placebo oral capsule: Placebo capsule matched to appearance of active drug. | 0 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial.
Source ClinicalTrials.gov
Trial
- Title
- Prazosin for Agitation in Alzheimer's Disease
- NCT number
- NCT03710642
- Phases
- PHASE2
- Conditions
- Alzheimer's Disease, Disruptive Behavior
- Interventions
- Prazosin, Placebo oral capsule
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Results first posted
- 2023-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03710642?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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