Comparison · NCT01143064-sae
BHR-100 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
Cite this record
ConductScience Library. BHR-100 vs Placebo: serious adverse events. Trial comparisons, record NCT01143064-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01143064-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 | 0.376 | 0.338 | 0.415 | wilson | |
| Risk in group 2 | 0.367 | 0.329 | 0.407 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00877 | -0.0463 | 0.0637 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.883 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.82 | 1.32 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BHR-100 than on Placebo | 114 | 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 | BHR-100 | Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs. | 224 | 596 | EG000 |
| Group 2 | Placebo | Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs. | 214 | 583 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
- NCT number
- NCT01143064
- Phases
- PHASE3
- Conditions
- Brain Injuries
- Interventions
- Progesterone, Lipid emulsion without progesterone
- Lead sponsor
- BHR Pharma, LLC
- Results first posted
- 2024-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01143064?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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