Comparison · NCT02344004-sae
LAI + Multi-drug Regimen vs Multi-drug Regimen: 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. LAI + Multi-drug Regimen vs Multi-drug Regimen: serious adverse events. Trial comparisons, record NCT02344004-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02344004-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 | 0.202 | 0.154 | 0.259 | wilson | |
| Risk in group 2 | 0.205 | 0.141 | 0.289 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00356 | -0.1 | 0.0828 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.628 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 0.978 | 0.557 | 1.72 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on LAI + Multi-drug Regimen than on Multi-drug Regimen | 281 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | LAI + 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 | 45 | 223 | EG000 |
| Group 2 | Multi-drug Regimen | Participants received their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines) | 23 | 112 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02344004?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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