Comparison · NCT01969799-sae
Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: 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. Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: serious adverse events. Trial comparisons, record NCT01969799-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01969799-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 | 0.394 | 0.289 | 0.511 | wilson | |
| Risk in group 2 | 0.375 | 0.272 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0194 | -0.137 | 0.175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.695 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.553 | 2.13 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Amikacin Fosfomycin Inhalation Solution than on Aerosolized Placebo | 51.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Amikacin Fosfomycin Inhalation Solution | 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.~Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System | 28 | 71 | EG000 |
| Group 2 | Aerosolized Placebo | Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System~Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System | 27 | 72 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 28 days
Source ClinicalTrials.gov
Trial
- Title
- Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
- NCT number
- NCT01969799
- Phases
- PHASE2
- Conditions
- Pneumonia, Bacterial
- Interventions
- Amikacin fosfomycin inhalation solution, Aerosolized placebo
- Lead sponsor
- Cardeas Pharma
- Results first posted
- 2017-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01969799?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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