Comparison · NCT03873987-sae
Orbactiv vs Kimrysa: 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. Orbactiv vs Kimrysa: serious adverse events. Trial comparisons, record NCT03873987-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03873987-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 | 0.0192 | 0.0034 | 0.101 | wilson | |
| Risk in group 2 | 0.04 | 0.011 | 0.135 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0208 | -0.117 | 0.0662 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.481 | 0.045 | 5.14 | log | |
| Odds ratio, group 1 over group 2 | 0.471 | 0.0413 | 5.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Orbactiv than on Kimrysa | 48.1 | 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 | Orbactiv | Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Orbactiv vials were reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. | 1 | 52 | EG000 |
| Group 2 | Kimrysa | A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimrysa vial was reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. | 2 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time of study drug initiation to Day 15
Source ClinicalTrials.gov
Trial
- Title
- Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
- NCT number
- NCT03873987
- Phases
- PHASE1
- Conditions
- Acute Bacterial Skin and Skin Structure Infection
- Interventions
- Current Formulation of Oritavancin, Kimyrsa
- Lead sponsor
- Melinta Therapeutics, Inc.
- Results first posted
- 2021-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03873987?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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