Comparison · NCT01662895-sae
Deferoxamine 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
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ConductScience Library. Deferoxamine vs Normal Saline: serious adverse events. Trial comparisons, record NCT01662895-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01662895-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 | 0.429 | 0.245 | 0.635 | wilson | |
| Risk in group 2 | 0.286 | 0.138 | 0.5 | wilson | |
| Risk difference, group 1 minus group 2 | 0.143 | -0.139 | 0.396 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.649 | 3.47 | log | |
| Odds ratio, group 1 over group 2 | 1.88 | 0.52 | 6.76 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Deferoxamine than on Normal Saline | 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 | Deferoxamine | Deferoxamine mesylate supplied in vials containing 2 gm of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. The reconstituted drug will be further diluted in normal saline to achieve a final concentration of 7.5 mg per ml.~Deferoxamine: Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset. | 9 | 21 | EG000 |
| Group 2 | Normal Saline | 0.9% sodium chloride~Normal saline: This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset. | 6 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events (serious and non-serious) were assessed until day-7 or discharge, whichever occurs earlier, and serious adverse events until day-90 (i.e. completion of the study) or withdrawal of consent.
Source ClinicalTrials.gov
Trial
- Title
- High-Dose Deferoxamine in Intracerebral Hemorrhage
- NCT number
- NCT01662895
- Phases
- PHASE2
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Deferoxamine, Normal saline
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Results first posted
- 2019-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01662895?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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