Comparison · NCT01940887-sae
E10030 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: 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. E10030 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: serious adverse events. Trial comparisons, record NCT01940887-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01940887-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 | 0.18 | 0.142 | 0.226 | wilson | |
| Risk in group 2 | 0.1 | 0.0717 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0801 | 0.0265 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.8 | 1.2 | 2.69 | log | |
| Odds ratio, group 1 over group 2 | 1.98 | 1.24 | 3.14 | log | |
| Number needed to harm, for one more participant with a serious adverse event on E10030 + Bevacizumab or Aflibercept than on Sham + Bevacizumab or Aflibercept | 12.5 | 7.47 | 37.8 | 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 | E10030 + Bevacizumab or Aflibercept | E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~E10030~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept | 58 | 322 | EG000 |
| Group 2 | Sham + Bevacizumab or Aflibercept | E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection~bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept~E10030 sham injection: Pressure on the eye with a syringe with no needle | 32 | 320 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
- NCT number
- NCT01940887
- Phases
- PHASE3
- Conditions
- Age-Related Macular Degeneration
- Interventions
- E10030, bevacizumab or aflibercept, E10030 sham injection
- Lead sponsor
- Ophthotech Corporation
- Results first posted
- 2020-09-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01940887?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
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GET https://conductscience.org/api/comparisons/v1/NCT01940887-sae