Comparison · NCT03403751-f52bdcea
Reltecimod 0.5 mg/kg vs Placebo: Serious Adverse Events (SAEs)
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. Reltecimod 0.5 mg/kg vs Placebo: Serious Adverse Events (SAEs). Trial comparisons, record NCT03403751-f52bdcea. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03403751-f52bdcea
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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 | 0.265 | 0.609 | wilson | |
| Risk in group 2 | 0.433 | 0.274 | 0.608 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00476 | -0.244 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.989 | 0.547 | 1.79 | log | |
| Odds ratio, group 1 over group 2 | 0.981 | 0.347 | 2.77 | log | |
| Number needed to treat, for one fewer participant with the outcome on Reltecimod 0.5 mg/kg than on Placebo | 210 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Reltecimod 0.5 mg/kg | Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) | 12 | 28 | OG000 |
| Group 2 | Placebo | Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) | 13 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Serious Adverse Events (SAEs)
- Description
- Number of patients experiencing at least one SAE
- Time frame
- 28 Days
- Population
This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
- NCT number
- NCT03403751
- Phases
- PHASE3
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Interventions
- Reltecimod 0.5 mg/kg, Placebo
- Lead sponsor
- Atox Bio Ltd
- Results first posted
- 2021-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03403751?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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