Comparison · NCT01431339-sae
Dalbavancin vs Vancomycin With Possible Switch to Oral 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. Dalbavancin vs Vancomycin With Possible Switch to Oral Linezolid: serious adverse events. Trial comparisons, record NCT01431339-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01431339-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 | 0.0326 | 0.0188 | 0.0561 | wilson | |
| Risk in group 2 | 0.0381 | 0.0229 | 0.063 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00554 | -0.034 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.855 | 0.401 | 1.82 | log | |
| Odds ratio, group 1 over group 2 | 0.85 | 0.388 | 1.86 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dalbavancin than on Vancomycin With Possible Switch to Oral Linezolid | 181 | 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 | Dalbavancin | IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 | 12 | 368 | EG000 |
| Group 2 | Vancomycin With Possible Switch to Oral Linezolid | Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days | 14 | 367 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- NCT number
- NCT01431339
- Phases
- PHASE3
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Interventions
- IV Dalbavancin, Vancomycin/Linezolid
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Results first posted
- 2014-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01431339?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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