Comparison · NCT04004208-sae
Aflibercept 0.4 mg vs Laser Photocoagulation: 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. Aflibercept 0.4 mg vs Laser Photocoagulation: serious adverse events. Trial comparisons, record NCT04004208-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04004208-sae
On this page
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 | 0.12 | 0.0644 | 0.213 | wilson | |
| Risk in group 2 | 0.263 | 0.15 | 0.42 | wilson | |
| Risk difference, group 1 minus group 2 | -0.143 | -0.31 | 0.00328 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.456 | 0.203 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.382 | 0.14 | 1.04 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Aflibercept 0.4 mg than on Laser Photocoagulation | 6.99 | 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 | Aflibercept 0.4 mg | One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated. | 9 | 75 | EG000 |
| Group 2 | Laser Photocoagulation | Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated. | 10 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- After the first administration and not later than 30 days after the last administration of study treatment, up to 24 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
- NCT number
- NCT04004208
- Phases
- PHASE3
- Conditions
- Retinopathy of Prematurity (ROP)
- Interventions
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Lead sponsor
- Bayer
- Results first posted
- 2022-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04004208?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04004208-sae