Comparison · NCT01799993-07335990
Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event
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. Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event. Trial comparisons, record NCT01799993-07335990. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01799993-07335990
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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 | 0.836 | 0.793 | 0.871 | wilson | |
| Risk in group 2 | 0.844 | 0.803 | 0.878 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00832 | -0.0625 | 0.0457 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.99 | 0.929 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.94 | 0.63 | 1.4 | log | |
| Number needed to treat, for one fewer participant with the outcome on Amikacin Inhale (BAY41-6551) than on Placebo | 120 | 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 (BAY41-6551) | Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10. | 295 | 353 | OG000 |
| Group 2 | Placebo | Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10. | 303 | 359 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event
- Description
AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).
- Time frame
- Up to 7 days after the end of study treatment
- Population
- ITT for Safety population (included all participants in ITT analysis set who were analyzed as treated for safety analyses)
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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