Comparison · NCT01892345-sae
Eculizumab vs Placebo: 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. Eculizumab vs Placebo: serious adverse events. Trial comparisons, record NCT01892345-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01892345-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 | 0.313 | 0.229 | 0.411 | wilson | |
| Risk in group 2 | 0.553 | 0.412 | 0.686 | wilson | |
| Risk difference, group 1 minus group 2 | -0.241 | -0.398 | -0.069 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.565 | 0.382 | 0.836 | log | |
| Odds ratio, group 1 over group 2 | 0.367 | 0.179 | 0.753 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Eculizumab than on Placebo | 4.15 | 2.51 | 14.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Eculizumab | Induction Period: Participants received eculizumab (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4).~Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards. | 30 | 96 | EG000 |
| Group 2 | Placebo | Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4).~Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards. | 26 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 to End of Study (211 Weeks)
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
- NCT number
- NCT01892345
- Phases
- PHASE3
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
- Interventions
- Eculizumab, Placebo
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2019-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01892345?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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