Comparison · NCT01788631-sae
Regadenoson Arm vs Placebo Arm: 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. Regadenoson Arm vs Placebo Arm: serious adverse events. Trial comparisons, record NCT01788631-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01788631-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 | 0.269 | 0.168 | 0.403 | wilson | |
| Risk in group 2 | 0.364 | 0.238 | 0.511 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0944 | -0.274 | 0.0889 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.74 | 0.409 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.645 | 0.271 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Regadenoson Arm than on Placebo Arm | 10.6 | 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 | Regadenoson Arm | 1.44 mcg/kg/hour infused over 48 hours~Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-\[4-\[(methylamino)carbonyl\]-1H-pyrazol-1-yl\]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes. | 14 | 52 | EG000 |
| Group 2 | Placebo Arm | Placebo infused over 48 hours~Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy. | 16 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were assessed from the time patients presented to the emergency department for their vaso-occlusive crisis through 30 days post- hospital discharge.
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Trial of Regadenoson in Sickle Cell Anemia
- NCT number
- NCT01788631
- Phases
- PHASE2
- Conditions
- Sickle Cell Anemia
- Interventions
- Regadenoson, Placebo
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2018-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01788631?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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