Comparison · NCT02694978-sae
Ferumoxytol vs Ferric Carboxymaltose (FCM): 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. Ferumoxytol vs Ferric Carboxymaltose (FCM): serious adverse events. Trial comparisons, record NCT02694978-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02694978-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 | 0.0361 | 0.0262 | 0.0496 | wilson | |
| Risk in group 2 | 0.035 | 0.0253 | 0.0483 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00111 | -0.0155 | 0.0177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.653 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.643 | 1.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ferumoxytol than on Ferric Carboxymaltose (FCM) | 902 | 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 | Ferumoxytol | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | 36 | 997 | EG000 |
| Group 2 | Ferric Carboxymaltose (FCM) | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. | 35 | 1,000 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
- NCT number
- NCT02694978
- Phases
- PHASE3
- Conditions
- Iron Deficiency Anemia
- Interventions
- Ferumoxytol, FCM
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Results first posted
- 2018-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02694978?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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