Comparison · NCT02819141-sae
Dexmedetomidine vs Control: 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. Dexmedetomidine vs Control: serious adverse events. Trial comparisons, record NCT02819141-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02819141-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 | 0.15 | 0.0879 | 0.244 | wilson | |
| Risk in group 2 | 0.0617 | 0.0267 | 0.136 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0883 | -0.00889 | 0.189 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.43 | 0.897 | 6.58 | log | |
| Odds ratio, group 1 over group 2 | 2.68 | 0.899 | 8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dexmedetomidine than on Control | 11.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dexmedetomidine | These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.~Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety. | 12 | 80 | EG001 |
| Group 2 | Control | These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team | 5 | 81 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
Source ClinicalTrials.gov
Trial
- Title
- Self-management of Sedative Therapy by Ventilated Patients
- NCT number
- NCT02819141
- Phases
- PHASE2, PHASE3
- Conditions
- Critical Illness, Anxiety, Respiratory Failure
- Interventions
- Dexmedetomidine
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2025-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02819141?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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