Comparison · NCT00987389-sae
Plasma Exchange vs No Plasma Exchange: 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. Plasma Exchange vs No Plasma Exchange: serious adverse events. Trial comparisons, record NCT00987389-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00987389-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 | 0.639 | 0.588 | 0.688 | wilson | |
| Risk in group 2 | 0.636 | 0.585 | 0.685 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00284 | -0.0679 | 0.0735 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.899 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.744 | 1.38 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Plasma Exchange than on No Plasma Exchange | 352 | 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 | Plasma Exchange | Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. | 225 | 352 | EG000 |
| Group 2 | No Plasma Exchange | Participants in this arm do not undergo plasma exchange | 224 | 352 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event data was collected from time of consent through study completion. The first subject was enrolled in June 2010, and the study completed in July 2017. Adverse event data was collected for 7 years and 1 month.
Source ClinicalTrials.gov
Trial
- Title
- Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
- NCT number
- NCT00987389
- Phases
- PHASE3
- Conditions
- Granulomatosis With Polyangiitis (Wegener's) (GPA), Microscopic Polyangiitis (MPA)
- Interventions
- Plasma Exchange, No Plasma Exchange, Glucocorticoids [Standard Dose], Glucocorticoids [Reduced Dose]
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2020-05-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00987389?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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