Comparison · NCT02378480-sae
Omadacycline vs Linezolid: 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. Omadacycline vs Linezolid: serious adverse events. Trial comparisons, record NCT02378480-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02378480-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 | 0.0372 | 0.0214 | 0.0638 | wilson | |
| Risk in group 2 | 0.0248 | 0.0126 | 0.0483 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0123 | -0.0159 | 0.0416 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.62 | 3.61 | log | |
| Odds ratio, group 1 over group 2 | 1.51 | 0.611 | 3.76 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Omadacycline than on Linezolid | 81.3 | 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 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 12 hours (q12h) (2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg oral administration q24h after a minimum of 3 days (6 doses) of IV treatment (6 overall IV doses because of the blinding). Participants received 4 active doses plus 2 placebo doses to maintain the blind. The total treatment duration was 7 to 14 days. | 12 | 323 | EG000 |
| Group 2 | Linezolid | Participants received linezolid 600 mg IV q12h with the option to switch to a 600 mg oral administration q12h after a minimum of 3 days (6 doses) of IV treatment. The total treatment duration was 7 to 14 days. | 8 | 322 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were assessed from the signing of Informed Consent Form to the time of the Final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article).
Source ClinicalTrials.gov
Trial
- Title
- Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
- NCT number
- NCT02378480
- Phases
- PHASE3
- Conditions
- Bacterial Infections, Skin Structures and Soft Tissue Infections
- Interventions
- Omadacycline, Linezolid
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Results first posted
- 2019-03-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02378480?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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