Comparison · NCT01950247-sae
Injectafer vs IV Iron Standard of Care (SOC): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Injectafer vs IV Iron Standard of Care (SOC): serious adverse events. Trial comparisons, record NCT01950247-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01950247-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 | 0.0078 | 0.00304 | 0.0199 | wilson | |
| Risk in group 2 | 0.00195 | 0.000345 | 0.011 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00584 | -0.00436 | 0.018 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.99 | 0.448 | 35.6 | log | |
| Odds ratio, group 1 over group 2 | 4.02 | 0.447 | 36.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Injectafer than on IV Iron Standard of Care (SOC) | 171 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Injectafer | 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.~Injectafer: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. | 4 | 513 | EG000 |
| Group 2 | IV Iron Standard of Care (SOC) | At a dose and administration regimen as determined by the study site investigator~SOC | 1 | 512 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 to Day 30
Source ClinicalTrials.gov
Trial
- Title
- Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
- NCT number
- NCT01950247
- Phases
- PHASE4
- Conditions
- Iron Deficiency Anemia (IDA)
- Interventions
- Injectafer, SOC
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2025-05-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01950247?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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