Comparison · NCT00358215-sae
Darbepoetin Alfa 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. Darbepoetin Alfa vs Placebo: serious adverse events. Trial comparisons, record NCT00358215-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00358215-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 | 0.689 | 0.662 | 0.716 | wilson | |
| Risk in group 2 | 0.65 | 0.622 | 0.677 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0393 | 0.000648 | 0.0778 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 1 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 1 | 1.42 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Darbepoetin Alfa than on Placebo | 25.4 | 12.8 | 1,540 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Darbepoetin Alfa | Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL. | 781 | 1,133 | EG001 |
| Group 2 | Placebo | Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa. | 741 | 1,140 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Informed consent to 30 days post treatment. Max time 72 months
Source ClinicalTrials.gov
Trial
- Title
- RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
- NCT number
- NCT00358215
- Phases
- PHASE3
- Conditions
- Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure
- Interventions
- Darbepoetin alfa, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2013-12-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00358215?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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