Comparison · NCT01799993-deaths
Amikacin Inhale 400mg q12h vs Placebo: deaths from any cause
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 Inhale 400mg q12h vs Placebo: deaths from any cause. Trial comparisons, record NCT01799993-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01799993-deaths
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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 | 0.244 | 0.202 | 0.291 | wilson | |
| Risk in group 2 | 0.237 | 0.196 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00686 | -0.0558 | 0.0695 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.792 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.736 | 1.46 | log | |
| Number needed to harm, for one more death from any cause on Amikacin Inhale 400mg q12h than on Placebo | 146 | 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 Inhale 400mg q12h | Patients received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via PDDS Clinical from Day 1 to Day 10. | 86 | 353 | EG000 |
| Group 2 | Placebo | Patients received 3.2 mL placebo solution aerosolized every 12 hours via PDDS Clinical from Day 1 to Day 10. | 85 | 359 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- After the first dose of study drug and no later than 7 days after end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
- NCT number
- NCT01799993
- Phases
- PHASE3
- Conditions
- Pneumonia, Bacterial
- Interventions
- Amikacin Inhalation Solution (BAY41-6551), Aerosolized Placebo
- Lead sponsor
- Bayer
- Results first posted
- 2018-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01799993?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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