Comparison · NCT02397057-sae
Injectafer vs Normal Saline: 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. Injectafer vs Normal Saline: serious adverse events. Trial comparisons, record NCT02397057-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02397057-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 | 0.0561 | 0.026 | 0.117 | wilson | |
| Risk in group 2 | 0.0396 | 0.0155 | 0.0974 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0165 | -0.0487 | 0.082 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.412 | 4.87 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.394 | 5.26 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Injectafer than on Normal Saline | 60.7 | 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 | Injectafer | Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.~Injectafer | 6 | 107 | EG000 |
| Group 2 | Normal Saline | IV Placebo (15ml of Normal Saline) IV push at 2ml/minute~Placebo | 4 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years, I month
Source ClinicalTrials.gov
Trial
- Title
- Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
- NCT number
- NCT02397057
- Phases
- PHASE3
- Conditions
- Restless Legs Syndrome (RLS)
- Interventions
- Injectafer, Placebo
- Lead sponsor
- American Regent, Inc.
- Results first posted
- 2021-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02397057?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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