Comparison · NCT01537393-sae
0-7d Preservation Time Group vs 8-14d Preservation Time Group: 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. 0-7d Preservation Time Group vs 8-14d Preservation Time Group: serious adverse events. Trial comparisons, record NCT01537393-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01537393-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 | 0.00148 | 0.000262 | 0.00834 | wilson | |
| Risk in group 2 | 0.00306 | 0.000839 | 0.0111 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00158 | -0.00969 | 0.00564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.484 | 0.044 | 5.33 | log | |
| Odds ratio, group 1 over group 2 | 0.484 | 0.0438 | 5.35 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 0-7d Preservation Time Group than on 8-14d Preservation Time Group | 634 | 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 | 0-7d Preservation Time Group | Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days. | 1 | 675 | EG000 |
| Group 2 | 8-14d Preservation Time Group | Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.~Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days. | 2 | 654 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- Cornea Preservation Time Study
- NCT number
- NCT01537393
- Phases
- PHASE4
- Conditions
- Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density
- Interventions
- Cornea tissue transplant, Cornea tissue transplant
- Lead sponsor
- Case Western Reserve University
- Results first posted
- 2018-04-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01537393?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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