Comparison · NCT03891875-sae
Elamipretide 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. Elamipretide vs Placebo: serious adverse events. Trial comparisons, record NCT03891875-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03891875-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 | 0.154 | 0.0996 | 0.23 | wilson | |
| Risk in group 2 | 0.102 | 0.0474 | 0.205 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0522 | -0.0642 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 0.634 | 3.61 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 0.601 | 4.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Elamipretide than on Placebo | 19.2 | 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 | Elamipretide | 40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period. | 18 | 117 | EG000 |
| Group 2 | Placebo | Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period. | 6 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 54 weeks
Source ClinicalTrials.gov
Trial
- Title
- ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
- NCT number
- NCT03891875
- Phases
- PHASE2
- Conditions
- Age-related Macular Degeneration
- Interventions
- Subcutaneous elamipretide through the elamipretide delivery system, Subcutaneos placebo through the elamipretide delivery system
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Results first posted
- 2023-10-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03891875?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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