Comparison · NCT03610646-sae
MYL-1701P vs Eylea: 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. MYL-1701P vs Eylea: serious adverse events. Trial comparisons, record NCT03610646-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03610646-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 | 0.174 | 0.125 | 0.237 | wilson | |
| Risk in group 2 | 0.131 | 0.0887 | 0.188 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0435 | -0.0321 | 0.119 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.81 | 2.19 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.782 | 2.52 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MYL-1701P than on Eylea | 23 | from the risk difference interval | the interval includes no difference |
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 | MYL-1701P | MYL-1701P~MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.~Additional doses were administered in accordance with the protocol. | 31 | 178 | EG000 |
| Group 2 | Eylea | Eylea~Eylea: Subjects received intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.~Additional doses were administered in accordance with the protocol. | 23 | 176 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to 52 Weeks
Source ClinicalTrials.gov
Trial
- Title
- Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
- NCT number
- NCT03610646
- Phases
- PHASE3
- Conditions
- Diabetic Macular Edema
- Interventions
- MYL-1701P, Eylea
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Results first posted
- 2023-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03610646?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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