Comparison · NCT04085601-sae
Overall Pegcetacoplan vs Standard of Care: 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. Overall Pegcetacoplan vs Standard of Care: serious adverse events. Trial comparisons, record NCT04085601-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04085601-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 | 0.13 | 0.0612 | 0.257 | wilson | |
| Risk in group 2 | 0.167 | 0.0584 | 0.392 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0362 | -0.272 | 0.13 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.783 | 0.219 | 2.8 | log | |
| Odds ratio, group 1 over group 2 | 0.75 | 0.166 | 3.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Overall Pegcetacoplan than on Standard of Care | 27.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Overall Pegcetacoplan | Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors. During the study, any subject assigned to the SoC reporting group (excluding complement inhibitors) who had an Hb concentration \>=2 g/dL below baseline or who presented with a qualifying thromboembolic event secondary to PNH was offered early escape therapy with pegcetacoplan. | 6 | 46 | EG000 |
| Group 2 | Standard of Care | Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy. | 3 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events were reported from the first dose of study medication and for up to 8 weeks after the last dose of study medication, approximately 34 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
- NCT number
- NCT04085601
- Phases
- PHASE3
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- APL-2
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Results first posted
- 2022-10-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04085601?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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