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Comparison · NCT02081963-sae

Nebulized Amikacin vs Nebulized Normal Saline: serious adverse events

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. Nebulized Amikacin vs Nebulized Normal Saline: serious adverse events. Trial comparisons, record NCT02081963-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02081963-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.0380.0130.106wilson
Risk in group 20.01370.002420.0736wilson
Risk difference, group 1 minus group 20.0243-0.04060.093newcombe hybrid score
Risk ratio, group 1 over group 22.770.29526.1log
Odds ratio, group 1 over group 22.840.28928log
Number needed to harm, for one more participant with a serious adverse event on Nebulized Amikacin than on Nebulized Normal Saline41.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Nebulized Amikacin
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.~Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
379EG000
Group 2Nebulized Normal Saline
Participants received nebulized normal saline BID for 14 days in combination with standard treatment.~Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
173EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
NCT number
NCT02081963
Phases
PHASE4
Conditions
Non-Cystic Fibrosis Bronchiectasis
Interventions
Amikacin, Normal saline
Lead sponsor
Qilu Hospital of Shandong University
Results first posted
2019-04-16

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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