Comparison · NCT01595438-sae
CAZ-AVI vs Doripenem: 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. CAZ-AVI vs Doripenem: serious adverse events. Trial comparisons, record NCT01595438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01595438-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 | 0.0411 | 0.027 | 0.062 | wilson | |
| Risk in group 2 | 0.0236 | 0.0135 | 0.0408 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0175 | -0.00468 | 0.0407 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.74 | 0.867 | 3.51 | log | |
| Odds ratio, group 1 over group 2 | 1.78 | 0.864 | 3.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CAZ-AVI than on Doripenem | 57.1 | 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 | CAZ-AVI | Ceftazidime-avibactam treatment group | 21 | 511 | EG000 |
| Group 2 | Doripenem | Doripenem treatment group | 12 | 509 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
- NCT number
- NCT01595438
- Phases
- PHASE3
- Conditions
- Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
- Interventions
- Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
- Lead sponsor
- Pfizer
- Results first posted
- 2016-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01595438?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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