Comparison · NCT00981045-545722dd
Ferric Carboxymaltose (FCM) vs Iron Sucrose (Venofer): Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
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 Iron Sucrose (Venofer): Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. Trial comparisons, record NCT00981045-545722dd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00981045-545722dd
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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 | 0.137 | 0.119 | 0.157 | wilson | |
| Risk in group 2 | 0.121 | 0.105 | 0.14 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0157 | -0.0103 | 0.0418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.924 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.913 | 1.45 | log | |
| Number needed to treat, for one more participant with the outcome on Ferric Carboxymaltose (FCM) than on Iron Sucrose (Venofer) | 63.5 | 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) | Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg | 175 | 1,276 | OG000 |
| Group 2 | Iron Sucrose (Venofer) | Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg | 156 | 1,285 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
- Description
The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.
- Time frame
- Day 120
- Population
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
- NCT number
- NCT00981045
- Phases
- PHASE3
- Conditions
- Iron Deficiency Anemia, Impaired Renal Function
- Interventions
- Ferric Carboxymaltose (FCM), Iron Sucrose (Venofer)
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2013-10-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00981045?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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