Comparison · NCT02877927-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 NCT02877927-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02877927-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 | 0.0136 | 0.00582 | 0.0314 | wilson | |
| Risk in group 2 | 0.0136 | 0.00583 | 0.0315 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000037 | -0.0195 | 0.0194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.291 | 3.42 | log | |
| Odds ratio, group 1 over group 2 | 0.997 | 0.286 | 3.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Omadacycline than on Linezolid | 27,000 | 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 omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets. | 5 | 368 | EG000 |
| Group 2 | Linezolid | Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. | 5 | 367 | 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 first dose of test article).
Source ClinicalTrials.gov
Trial
- Title
- Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
- NCT number
- NCT02877927
- Phases
- PHASE3
- Conditions
- Bacterial Infections, Skin Structures and Soft Tissue Infections
- Interventions
- Omadacycline, Linezolid
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Results first posted
- 2018-11-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02877927?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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