Comparison · NCT00597701-sae
Baclofen vs Placebo: 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. Baclofen vs Placebo: serious adverse events. Trial comparisons, record NCT00597701-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00597701-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 | 0.08 | 0.0222 | 0.25 | wilson | |
| Risk in group 2 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0274 | -0.175 | 0.202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.52 | 0.149 | 15.5 | log | |
| Odds ratio, group 1 over group 2 | 1.57 | 0.131 | 18.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Baclofen than on Placebo | 36.5 | 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 | Baclofen | Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. | 2 | 25 | EG000 |
| Group 2 | Placebo | Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours. | 1 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Treating Alcohol Withdrawal With Oral Baclofen
- NCT number
- NCT00597701
- Phases
- NA
- Conditions
- Alcohol Withdrawal Delirium
- Interventions
- Baclofen, Placebo, Lorazepam
- Lead sponsor
- Essentia Health
- Results first posted
- 2011-07-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00597701?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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