Comparison · NCT04611152-sae
KSI-301 (Arm A) vs Aflibercept (Arm B): 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. KSI-301 (Arm A) vs Aflibercept (Arm B): serious adverse events. Trial comparisons, record NCT04611152-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04611152-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 | 0.265 | 0.212 | 0.326 | wilson | |
| Risk in group 2 | 0.222 | 0.173 | 0.28 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0435 | -0.035 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.865 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.826 | 1.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on KSI-301 (Arm A) than on Aflibercept (Arm B) | 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 | KSI-301 (Arm A) | Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100.~KSI-301: Intravitreal Injection~Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 61 | 230 | EG000 |
| Group 2 | Aflibercept (Arm B) | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100.~Aflibercept: Intravitreal Injection~Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 51 | 230 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64.
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
- NCT number
- NCT04611152
- Phases
- PHASE3
- Conditions
- Diabetic Macular Edema
- Interventions
- KSI-301, Aflibercept, Sham Procedure
- Lead sponsor
- Kodiak Sciences Inc
- Results first posted
- 2024-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04611152?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/NCT04611152-sae