Comparison · NCT00713193-deaths
CSA Arm vs Prednisone Arm: 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. CSA Arm vs Prednisone Arm: deaths from any cause. Trial comparisons, record NCT00713193-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00713193-deaths
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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 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk in group 2 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0119 | -0.241 | 0.289 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.0814 | 16.7 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.066 | 21.2 | log | |
| Number needed to harm, for one more death from any cause on CSA Arm than on Prednisone Arm | 84 | 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 | CSA Arm | Patients in this arm will receive cyclosporine (Neoral) at a dose of 2-3 mg/kg orally as an adjunct to plasma exchange.~All patients initiated daily PEX (one plasma volume), using plasma as the replacement fluid. Patients randomized to the CSA arm received CSA at a dose of 2-3 mg/kg (rounded to the nearest 50 mg increment) divided into a twice daily dosing (Figure 1a). Patients randomized to CSA did not receive steroids, but were permitted to receive hydrocortisone as required for any hypersensitivity reactions to the infused plasma. Daily PEX was continued until a clinical response was achieved, then patients received PEX every other day for 2 additional procedures, with the first day that the platelet count and LDH were normal counting as the first of the 2 procedures.~Cyclosporine: 2-3 mg/kg orally in a twice day divided dose for 6 months | 1 | 12 | EG000 |
| Group 2 | Prednisone Arm | Patients in this arm will receive prednisone at a dose of 1 mg/kg as an adjunct to plasma exchange.~All patients initiated daily PEX (one plasma volume), using plasma as the replacement fluid. Patients randomized to the corticosteroid arm received prednisone at a dose of 1 mg/kg/d rounded to the nearest 20 mg increment. Daily PEX was continued until a clinical response was achieved, then patients received PEX every other day for 2 additional procedures, with the first day that the platelet count and LDH were normal counting as the first of the 2 procedures.~Prednisone: 1 mg/kg orally, daily for at least 30 days, then tapered over 30 days after achieving remission. | 1 | 14 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
- NCT number
- NCT00713193
- Phases
- PHASE3
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Interventions
- Cyclosporine, Prednisone
- Lead sponsor
- Ohio State University
- Results first posted
- 2023-04-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00713193?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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