Comparison · NCT02680756-sae
Oral Ferric Iron Compound vs Intravenous Iron: 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. Oral Ferric Iron Compound vs Intravenous Iron: serious adverse events. Trial comparisons, record NCT02680756-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02680756-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 | 0.0945 | 0.0549 | 0.158 | wilson | |
| Risk in group 2 | 0.0333 | 0.013 | 0.0826 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0612 | -0.00204 | 0.128 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.83 | 0.94 | 8.55 | log | |
| Odds ratio, group 1 over group 2 | 3.03 | 0.948 | 9.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Oral Ferric Iron Compound than on Intravenous Iron | 16.4 | 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 | Oral Ferric Iron Compound | 30 mg capsules to be taken orally twice a day~Ferric Maltol | 12 | 127 | EG000 |
| Group 2 | Intravenous Iron | Administered as per the local SmPC/PI~Ferric Carboxymaltose | 4 | 120 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed)
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
- NCT number
- NCT02680756
- Phases
- PHASE3
- Conditions
- Anemia, Iron-Deficiency, Inflammatory Bowel Disease, Crohn's Disease
- Interventions
- Ferric Maltol, Ferric Carboxy Maltose
- Lead sponsor
- Shield Therapeutics
- Results first posted
- 2020-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02680756?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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