Comparison · NCT03301467-sae
Avacopan Group vs Placebo 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. Avacopan Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT03301467-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03301467-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 | 0.107 | 0.0371 | 0.272 | wilson | |
| Risk in group 2 | 0.103 | 0.0358 | 0.264 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00369 | -0.171 | 0.182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.228 | 4.71 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.192 | 5.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Avacopan Group than on Placebo Group | 271 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Avacopan Group | Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period~Avacopan: Orally administered~The safety population included all subjects who were randomized and had received at least one dose of study drug. | 3 | 28 | EG001 |
| Group 2 | Placebo Group | Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period~Avacopan-matching placebo: Orally administered~The safety population included all subjects who were randomized and had received at least one dose of study drug. | 3 | 29 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From day 1 throughout the study period (day 182/week 26)
Source ClinicalTrials.gov
Trial
- Title
- Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
- NCT number
- NCT03301467
- Phases
- PHASE2
- Conditions
- C3 Glomerulopathy (C3G)
- Interventions
- Avacopan, Avacopan Matching Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2022-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03301467?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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