Comparison · NCT02486627-sae
Plazomicin vs Meropenem: 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. Plazomicin vs Meropenem: serious adverse events. Trial comparisons, record NCT02486627-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02486627-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 | 0.0165 | 0.00707 | 0.038 | wilson | |
| Risk in group 2 | 0.0166 | 0.00712 | 0.0383 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00011 | -0.0238 | 0.0234 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.993 | 0.291 | 3.4 | log | |
| Odds ratio, group 1 over group 2 | 0.993 | 0.285 | 3.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Plazomicin than on Meropenem | 9,120 | 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 | Plazomicin | Patients received up to 15 mg/kg plazomicin as an IV infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral). | 5 | 303 | EG000 |
| Group 2 | Meropenem | Patients received 1.0 g meropenem as an IV infusion q8h. After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral). | 5 | 301 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Day 32
Source ClinicalTrials.gov
Trial
- Title
- A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
- NCT number
- NCT02486627
- Phases
- PHASE3
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- plazomicin, meropenem, levofloxacin (oral)
- Lead sponsor
- Achaogen, Inc.
- Results first posted
- 2018-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02486627?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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