Comparison · NCT00704353-sae
Ferric Carboxymaltose (FCM) vs Standard Medical Care: 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 (FCM) vs Standard Medical Care: serious adverse events. Trial comparisons, record NCT00704353-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00704353-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 | 0.0137 | 0.00585 | 0.0316 | wilson | |
| Risk in group 2 | 0.0244 | 0.0129 | 0.0457 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0107 | -0.0334 | 0.0106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.56 | 0.19 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.554 | 0.184 | 1.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ferric Carboxymaltose (FCM) than on Standard Medical Care | 93.2 | from the risk difference interval | the interval includes no difference |
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) | Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. | 5 | 366 | EG000 |
| Group 2 | Standard Medical Care | Received standard medical care (as determined by the Investigator) of IDA. | 9 | 369 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
- NCT number
- NCT00704353
- Phases
- PHASE3
- Conditions
- Anemia
- Interventions
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2013-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00704353?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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