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Comparison · NCT02994927-sae

Prednisone Group vs Avacopan 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

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ConductScience Library. Prednisone Group vs Avacopan Group: serious adverse events. Trial comparisons, record NCT02994927-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02994927-sae

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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 10.4510.3770.528wilson
Risk in group 20.4220.3490.498wilson
Risk difference, group 1 minus group 20.0295-0.07670.135newcombe hybrid score
Risk ratio, group 1 over group 21.070.8371.37log
Odds ratio, group 1 over group 21.130.731.74log
Number needed to harm, for one more participant with a serious adverse event on Prednisone Group than on Avacopan Group33.9from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Prednisone Group
Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. The safety population included all subjects who were randomized and had received at least one dose of study drug.
74164EG000
Group 2Avacopan Group
Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. The safety population included all subjects who were randomized and had received at least one dose of study drug.
70166EG001

Harm

What it counts
Total, serious adverse events
Time frame
From day 1 throughout the study period (day 421/week 60)

Source ClinicalTrials.gov

Trial

Title
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
NCT number
NCT02994927
Phases
PHASE3
Conditions
ANCA-Associated Vasculitis
Interventions
Avacopan, Prednisone, Cyclophosphamide, Rituximab, Azathioprine
Lead sponsor
Amgen
Results first posted
2022-09-09

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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