Comparison · NCT02499354-81563b2a
Oral Iron vs IV Iron: Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.
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. Oral Iron vs IV Iron: Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment. Trial comparisons, record NCT02499354-81563b2a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02499354-81563b2a
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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 | 0.478 | 0.341 | 0.619 | wilson | |
| Risk in group 2 | 0.234 | 0.136 | 0.372 | wilson | |
| Risk difference, group 1 minus group 2 | 0.244 | 0.0496 | 0.415 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.04 | 1.12 | 3.72 | log | |
| Odds ratio, group 1 over group 2 | 3 | 1.23 | 7.3 | log | |
| Number needed to treat, for one more participant with the outcome on Oral Iron than on IV Iron | 4.09 | 2.41 | 20.2 | from the risk difference interval |
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 Iron | Ferrous Sulfate 325mg (oral) tabs morning and evening~Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening~In this arm participants also received intravenous normal saline as part of a double blind, double dummy design | 22 | 46 | OG000 |
| Group 2 | IV Iron | Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart~Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart~In this arm participants received oral vitamin C as part of a double blind, double dummy design | 11 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.
- Description
- Patient reported gastrointestinal or constitutional adverse events
- Time frame
- Up to six weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
- NCT number
- NCT02499354
- Phases
- PHASE2
- Conditions
- Restless Legs Syndrome, Iron Deficiency Anemia
- Interventions
- Ferumoxytol intravenous, Ferrous sulfate
- Lead sponsor
- Auerbach Hematology Oncology Associates P C
- Results first posted
- 2023-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02499354?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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