Comparison · NCT03037931-sae
Ferric Carboxymaltose 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. Ferric Carboxymaltose vs Placebo: serious adverse events. Trial comparisons, record NCT03037931-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03037931-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 | 0.27 | 0.248 | 0.292 | wilson | |
| Risk in group 2 | 0.262 | 0.24 | 0.284 | wilson | |
| Risk difference, group 1 minus group 2 | 0.008 | -0.0233 | 0.0392 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.916 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.888 | 1.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ferric Carboxymaltose than on Placebo | 125 | 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 | Ferric Carboxymaltose | Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.~Ferric Carboxymaltose: Intravenous Iron | 413 | 1,532 | EG000 |
| Group 2 | Placebo | Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.~Placebo: Normal Saline Solution | 401 | 1,533 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 67.5 months
Source ClinicalTrials.gov
Trial
- Title
- Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
- NCT number
- NCT03037931
- Phases
- PHASE3
- Conditions
- Heart Failure, Iron-deficiency
- Interventions
- Ferric Carboxymaltose, Placebo
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2024-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03037931?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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