Comparison · NCT03485950-b2fc31d5
Ceftolozane/Tazobactam Arm vs Standard of Care (SOC) Arm: Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU)
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 MITT Analysis Set at Late Follow-Up (LFU). Trial comparisons, record NCT03485950-b2fc31d5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03485950-b2fc31d5
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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 | 0.702 | 0.56 | 0.813 | wilson | |
| Risk in group 2 | 0.52 | 0.385 | 0.652 | wilson | |
| Risk difference, group 1 minus group 2 | 0.182 | -0.0117 | 0.357 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 0.976 | 1.87 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 0.943 | 5.02 | log | |
| Number needed to treat, for one more participant with the outcome on Ceftolozane/Tazobactam Arm than on Standard of Care (SOC) Arm | 5.49 | from the risk difference interval | the interval includes no difference |
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. | 33 | 47 | 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. | 26 | 50 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Favorable Clinical Response in the MITT Analysis Set at Late Follow-Up (LFU)
- Description
The secondary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at late follow-up (LFU). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
- Time frame
- 35 to 42 days after the start of inpatient IV study drug
- Population
- Patients in the MITT (Modified Intent-To-Treat) 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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