Comparison · NCT01997229-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
Cite this record
ConductScience Library. Eculizumab vs Placebo: serious adverse events. Trial comparisons, record NCT01997229-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01997229-sae
On this page
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 | 0.145 | 0.0783 | 0.253 | wilson | |
| Risk in group 2 | 0.286 | 0.189 | 0.407 | wilson | |
| Risk difference, group 1 minus group 2 | -0.141 | -0.279 | 0.0046 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.508 | 0.247 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.425 | 0.174 | 1.04 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Eculizumab than on Placebo | 7.11 | 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 | Eculizumab | Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26). | 9 | 62 | EG000 |
| Group 2 | Placebo | Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).~Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26). | 18 | 63 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 26 weeks (Study Period) + 8 weeks (Follow-up Period for subjects who discontinued the Study Period or completed the Study Period but did not enroll in the ECU-MG-302 extension trial)
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
- NCT number
- NCT01997229
- Phases
- PHASE3
- Conditions
- Refractory Generalized Myasthenia Gravis
- Interventions
- Eculizumab, Placebo
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2018-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01997229?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01997229-sae