Comparison · NCT01287078-sae
Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: 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. Inhaled Cyclosporine in HSCT Recipients vs Inhaled Cyclosporine in Lung Transplant Recipients: serious adverse events. Trial comparisons, record NCT01287078-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01287078-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 | 0.25 | 0.112 | 0.469 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0.25 | -0.328 | 0.469 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Inhaled Cyclosporine in HSCT Recipients than on Inhaled Cyclosporine in Lung Transplant Recipients | 4 | 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 | Inhaled Cyclosporine in HSCT Recipients | Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. | 5 | 20 | EG000 |
| Group 2 | Inhaled Cyclosporine in Lung Transplant Recipients | Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19. | 0 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 18 weeks
Source ClinicalTrials.gov
Trial
- Title
- Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
- NCT number
- NCT01287078
- Phases
- PHASE2
- Conditions
- Constrictive Bronchiolitis, Bronchiolitis Obliterans, Graft vs Host Disease, Bronchiolitis, Exudative, Bronchiolitis, Proliferative
- Interventions
- Cyclosporine Inhalation Solution
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Results first posted
- 2020-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01287078?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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