Comparison · NCT03472885-sae
24-Week Treatment Period: Danicopan + Eculizumab vs LTE Period: Danicopan + Eculizumab: 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. 24-Week Treatment Period: Danicopan + Eculizumab vs LTE Period: Danicopan + Eculizumab: serious adverse events. Trial comparisons, record NCT03472885-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03472885-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 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk in group 2 | 0.636 | 0.354 | 0.848 | wilson | |
| Risk difference, group 1 minus group 2 | -0.47 | -0.713 | -0.0709 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.262 | 0.0685 | 1 | log | |
| Odds ratio, group 1 over group 2 | 0.114 | 0.0162 | 0.806 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 24-Week Treatment Period: Danicopan + Eculizumab than on LTE Period: Danicopan + Eculizumab | 2.13 | 1.4 | 14.1 | from the risk difference interval |
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 | 24-Week Treatment Period: Danicopan + Eculizumab | Participants were administered 100, 150, or 200 mg danicopan TID in combination with eculizumab for 24 weeks. Danicopan dose may have been increased within each participant, to a maximum of 200 mg TID based on safety and efficacy. | 2 | 12 | EG000 |
| Group 2 | LTE Period: Danicopan + Eculizumab | After completing the 24-Week Treatment Period, participants who received clinical benefit (as assessed by the Investigator based on improvement in hemoglobin) continued into the LTE and received the same dose of danicopan plus eculizumab treatment as that received at the end of the 24-Week Treatment Period. | 7 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 (after dosing) through end of study (maximum exposure: 1631 days)
Source ClinicalTrials.gov
Trial
- Title
- Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab
- NCT number
- NCT03472885
- Phases
- PHASE2
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- Danicopan, Eculizumab
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2021-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03472885?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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