Comparison · NCT02066402-sae
Tedizolid Phosphate (Sivextro, BAY119-2631) 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. Tedizolid Phosphate (Sivextro, BAY119-2631) vs Linezolid: serious adverse events. Trial comparisons, record NCT02066402-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02066402-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 | 0.0377 | 0.0212 | 0.0662 | wilson | |
| Risk in group 2 | 0.0269 | 0.0137 | 0.0522 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0107 | -0.0195 | 0.0422 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.571 | 3.43 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 0.561 | 3.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tedizolid Phosphate (Sivextro, BAY119-2631) than on Linezolid | 93.2 | 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 | Tedizolid Phosphate (Sivextro, BAY119-2631) | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo | 11 | 292 | EG000 |
| Group 2 | Linezolid | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days | 8 | 297 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the start of study drug administration until last subject last visit.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- NCT number
- NCT02066402
- Phases
- PHASE3
- Conditions
- Bacterial Infections
- Interventions
- Tedizolid (BAY119-2631), Placebo Tedizolid (BAY119-2631), Linezolid, Placebo Linezolid
- Lead sponsor
- Bayer
- Results first posted
- 2017-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02066402?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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