Comparison · NCT01650545-sae
Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: 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. Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: serious adverse events. Trial comparisons, record NCT01650545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01650545-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 | 0.727 | 0.434 | 0.903 | wilson | |
| Risk in group 2 | 0.8 | 0.49 | 0.943 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0727 | -0.399 | 0.283 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.909 | 0.565 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.0867 | 5.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Liposomal Aerosol Cyclosporine than on Conventional Oral Immune Suppression | 13.7 | 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 | Liposomal Aerosol Cyclosporine | Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )~Liposomal aerosol cyclosporine: inhaled form of immune suppression~standard immune suppression, oral: conventional drug | 8 | 11 | EG000 |
| Group 2 | Conventional Oral Immune Suppression | Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone~standard immune suppression, oral: conventional drug | 8 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious and non-serious adverse events monitored for one year as described in the IND. All cause mortality monitored out to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
- NCT number
- NCT01650545
- Phases
- PHASE1, PHASE2
- Conditions
- Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
- Interventions
- Liposomal aerosol cyclosporine, standard immune suppression, oral
- Lead sponsor
- University of Maryland, Baltimore
- Results first posted
- 2017-10-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01650545?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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