Comparison · NCT00973102-sae
Premarin IV 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. Premarin IV vs Placebo: serious adverse events. Trial comparisons, record NCT00973102-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00973102-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 | 0.217 | 0.0966 | 0.419 | wilson | |
| Risk in group 2 | 0.28 | 0.143 | 0.476 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0626 | -0.293 | 0.181 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.776 | 0.286 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 0.714 | 0.191 | 2.68 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Premarin IV than on Placebo | 16 | 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 | Premarin IV | Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.~Premarin IV: One time dose of Premarin IV | 5 | 23 | EG000 |
| Group 2 | Placebo | Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.~Placebo: One time dose of placebo. | 7 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
- NCT number
- NCT00973102
- Phases
- PHASE2
- Conditions
- Hemorrhagic Shock
- Interventions
- Premarin IV, Placebo
- Lead sponsor
- University of Texas Southwestern Medical Center
- Results first posted
- 2020-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00973102?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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