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Comparison · NCT01650545-deaths

Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: 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. Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression: deaths from any cause. Trial comparisons, record NCT01650545-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01650545-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 10.5450.280.787wilson
Risk in group 210.7221wilson
Risk difference, group 1 minus group 2-0.455-0.72-0.0864newcombe hybrid score
Risk ratio, group 1 over group 20.5450.3180.936log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer death from any cause on Liposomal Aerosol Cyclosporine than on Conventional Oral Immune Suppression2.21.3911.6from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Liposomal 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
611EG000
Group 2Conventional 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
1010EG001

Harm

What it counts
Total, all-cause mortality
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

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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