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Comparison · NCT02344004-deaths

LAI + Multi-drug Regimen vs Multi-drug Regimen: 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

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ConductScience Library. LAI + Multi-drug Regimen vs Multi-drug Regimen: deaths from any cause. Trial comparisons, record NCT02344004-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02344004-deaths

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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 10.04930.02780.0862wilson
Risk in group 20.07140.03660.135wilson
Risk difference, group 1 minus group 2-0.0221-0.08890.0286newcombe hybrid score
Risk ratio, group 1 over group 20.6910.2861.67log
Odds ratio, group 1 over group 20.6750.2631.73log
Number needed to treat, for one fewer death from any cause on LAI + Multi-drug Regimen than on Multi-drug Regimen45.2from 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 1LAI + Multi-drug Regimen
Participants received LAI 590 mg QD in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines); LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes
11223EG000
Group 2Multi-drug RegimenParticipants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)8112EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Treatment-emergent adverse events (AEs) were assessed at Baseline (Day 1) and all subsequent study visits through Month 28 (end of study).

Source ClinicalTrials.gov

Trial

Title
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
NCT number
NCT02344004
Phases
PHASE3
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
LAI (Liposomal Amikacin for Inhalation) 590 mg
Lead sponsor
Insmed Incorporated
Results first posted
2018-11-20

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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