Comparison · NCT00548860-10b6c836
Ferric Carboxymaltose (FCM) vs Standard Medical Care (SMC): Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
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 (FCM) vs Standard Medical Care (SMC): Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. Trial comparisons, record NCT00548860-10b6c836. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00548860-10b6c836
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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 | 0.00602 | 0.00276 | 0.0131 | wilson | |
| Risk in group 2 | 0.0215 | 0.0143 | 0.0324 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0155 | -0.0268 | -0.00537 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.28 | 0.114 | 0.687 | log | |
| Odds ratio, group 1 over group 2 | 0.275 | 0.111 | 0.682 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ferric Carboxymaltose (FCM) than on Standard Medical Care (SMC) | 64.5 | 37.3 | 186 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ferric Carboxymaltose (FCM) | Intravenous (IV) iron | 6 | 996 | OG000 |
| Group 2 | Standard Medical Care (SMC) | SMC for postpartum and heavy uterine bleeding subjects with anemia | 22 | 1,022 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
- Description
- Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
- Time frame
- From Day 0 through 30 days after the last dose of study drug.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
- NCT number
- NCT00548860
- Phases
- PHASE3
- Conditions
- Anemia
- Interventions
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2015-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00548860?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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