Comparison · NCT03150589-sae
SB11 (Proposed Ranibizumab Biosimilar) vs Lucentis (Ranibizumab): 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. SB11 (Proposed Ranibizumab Biosimilar) vs Lucentis (Ranibizumab): serious adverse events. Trial comparisons, record NCT03150589-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03150589-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 | 0.149 | 0.115 | 0.19 | wilson | |
| Risk in group 2 | 0.147 | 0.114 | 0.188 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00168 | -0.051 | 0.0544 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.709 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.668 | 1.54 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SB11 (Proposed Ranibizumab Biosimilar) than on Lucentis (Ranibizumab) | 596 | 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 | SB11 (Proposed Ranibizumab Biosimilar) | SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks | 52 | 350 | EG000 |
| Group 2 | Lucentis (Ranibizumab) | Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks | 52 | 354 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
Source ClinicalTrials.gov
Trial
- Title
- A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- NCT number
- NCT03150589
- Phases
- PHASE3
- Conditions
- Age-Related Macular Degeneration
- Interventions
- SB11 (Proposed ranibizumab biosimilar), Lucentis (ranibizumab)
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Results first posted
- 2021-05-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03150589?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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