Comparison · NCT03485950-99062bd6
Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV. Trial comparisons, record NCT03485950-99062bd6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03485950-99062bd6
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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 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ceftolozane/Tazobactam Arm | Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy. | 2 | 2 | OG000 |
| Group 2 | Standard of Care (SOC) Arm | Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. | 1 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Favorable Clinical Response in the ME Analysis Set at EOIV.
- Description
The secondary efficacy outcome is favorable clinical response of the patients in the ME (Microbiologically Evaluable) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
- Time frame
- Within 72 hours after administration of the last dose of inpatient IV study drug.
- Population
- Patients in CE analysis set with baseline Gram-negative pathogen (= ME (Microbiologically Evaluable) Analysis Set)
Source ClinicalTrials.gov
Trial
- Title
- Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
- NCT number
- NCT03485950
- Phases
- PHASE2
- Conditions
- Other Infectious Diseases
- Interventions
- Cefepime, Ceftolozane, Laboratory Biomarker Analysis, Meropenem, Piperacillin-Tazobactam, Tazobactam
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2021-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03485950?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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