Comparison · NCT02469857-249788b1
AB103 0.5 mg/kg vs Placebo: Number of Patients With One or More Adverse Events (AEs)
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. AB103 0.5 mg/kg vs Placebo: Number of Patients With One or More Adverse Events (AEs). Trial comparisons, record NCT02469857-249788b1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02469857-249788b1
On this page
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 | 0.727 | 0.649 | 0.794 | wilson | |
| Risk in group 2 | 0.653 | 0.573 | 0.725 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0742 | -0.0322 | 0.178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.954 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 1.42 | 0.859 | 2.34 | log | |
| Number needed to treat, for one more participant with the outcome on AB103 0.5 mg/kg than on Placebo | 13.5 | 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 | AB103 0.5 mg/kg | AB103 0.5 mg/kg, IV infusion, single dose | 104 | 143 | OG000 |
| Group 2 | Placebo | NaCl 0.9%, IV infusion, single dose | 96 | 147 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With One or More Adverse Events (AEs)
- Description
- Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.
- Time frame
- 28 days
- Population
- As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02469857-249788b1