Comparison · NCT02469857-5ba0f312
Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE
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. Reltecimod (AB103) 0.5 mg/kg vs Placebo: Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE. Trial comparisons, record NCT02469857-5ba0f312. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02469857-5ba0f312
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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 | 0.507 | 0.396 | 0.617 | wilson | |
| Risk in group 2 | 0.321 | 0.214 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | 0.185 | 0.0142 | 0.339 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.58 | 1.01 | 2.45 | log | |
| Odds ratio, group 1 over group 2 | 2.17 | 1.05 | 4.46 | log | |
| Number needed to treat, for one more participant with the outcome on Reltecimod (AB103) 0.5 mg/kg than on Placebo | 5.4 | 2.95 | 70.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Reltecimod (AB103) 0.5 mg/kg | Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes | 38 | 75 | OG000 |
| Group 2 | Placebo | NaCl 0.9%, single IV infusion over approximately 10 minutes | 18 | 56 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE
- Description
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.
- Time frame
- 28 days
- Population
The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.
Source ClinicalTrials.gov
Trial
- Title
- Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
- NCT number
- NCT02469857
- Phases
- PHASE3
- Conditions
- Necrotizing Soft Tissue Infections, Necrotizing Fasciitis, Fournier's Gangrene
- Interventions
- AB103 0.5 mg/kg, NaCl 0.9%
- Lead sponsor
- Atox Bio Ltd
- Results first posted
- 2021-10-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02469857?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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