Comparison · NCT04677543-sae
ALIS + Background Regimen (Azithromycin + Ethambutol) vs ELC + Background Regimen (Azithromycin + Ethambutol): 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. ALIS + Background Regimen (Azithromycin + Ethambutol) vs ELC + Background Regimen (Azithromycin + Ethambutol): serious adverse events. Trial comparisons, record NCT04677543-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04677543-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 | 0.146 | 0.0725 | 0.272 | wilson | |
| Risk in group 2 | 0.0588 | 0.0202 | 0.159 | wilson | |
| Risk difference, group 1 minus group 2 | 0.087 | -0.0373 | 0.219 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.48 | 0.68 | 9.04 | log | |
| Odds ratio, group 1 over group 2 | 2.73 | 0.663 | 11.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ALIS + Background Regimen (Azithromycin + Ethambutol) than on ELC + Background Regimen (Azithromycin + Ethambutol) | 11.5 | 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 | ALIS + Background Regimen (Azithromycin + Ethambutol) | Participants received 590 mg of ALIS once daily. Participants also received the background regimen of azithromycin 250 mg and ethambutol 15 mg/kg tablets orally, once daily. | 7 | 48 | EG000 |
| Group 2 | ELC + Background Regimen (Azithromycin + Ethambutol) | Participants received ELC, a matching placebo to ALIS, once daily. Participants also received the background regimen of azithromycin 250 mg and ethambutol 15 mg/kg tablets orally, once daily. | 3 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to Month 7
Source ClinicalTrials.gov
Trial
- Title
- Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
- NCT number
- NCT04677543
- Phases
- PHASE3
- Conditions
- Mycobacterium Infections, Nontuberculous
- Interventions
- ALIS, Azithromycin, Ethambutol, ELC
- Lead sponsor
- Insmed Incorporated
- Results first posted
- 2024-06-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04677543?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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