Comparison · NCT03657342-sae
L-CsA treatment plus SoC (SAF) vs SoC alone (SAF): 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. L-CsA treatment plus SoC (SAF) vs SoC alone (SAF): serious adverse events. Trial comparisons, record NCT03657342-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03657342-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 | 0.625 | 0.453 | 0.771 | wilson | |
| Risk in group 2 | 0.467 | 0.302 | 0.639 | wilson | |
| Risk difference, group 1 minus group 2 | 0.158 | -0.0852 | 0.378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 0.839 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 1.9 | 0.691 | 5.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on L-CsA treatment plus SoC (SAF) than on SoC alone (SAF) | 6.32 | 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 | L-CsA treatment plus SoC (SAF) | Liposomal Cyclosporine A 5 mg twice daily for 48 weeks + Standard of Care Therapy~Liposomal Cyclosporine A: This formulation is developed for inhalation use and delivered via the PARI eFlow® Device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm | 20 | 32 | EG000 |
| Group 2 | SoC alone (SAF) | In this control arm only the standard of care is administered. Standard of care is a maintenance regimen of immunosuppressive agents.~standard of care: Standard of Care Therapy. Eligible patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent. The regimen must be stable within 4 weeks prior to randomization with respect to the therapeutic agents. Patients receiving azithromycin for prophylaxis or treatment of BOS, must be on a stable regimen for a least 4-weeks prior to randomization and will continue to receive azithromycin during the trial as deemed appropriate by the investigator. | 14 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Permanent assessment throughout the complete clinical trial period, from baseline (Week 0, Day 1, V1) till week 48 (V9)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
- NCT number
- NCT03657342
- Phases
- PHASE3
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications, Lung Transplant Failure and Rejection, Chronic Lung Allograft Dysfunction
- Interventions
- Liposomal Cyclosporine A, standard of care
- Lead sponsor
- Zambon SpA
- Results first posted
- 2025-10-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03657342?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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