Comparison · NCT04101721-sae
Laser Photocoagulation vs Aflibercept 0.4 mg: 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. Laser Photocoagulation vs Aflibercept 0.4 mg: serious adverse events. Trial comparisons, record NCT04101721-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04101721-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 | 0.444 | 0.276 | 0.627 | wilson | |
| Risk in group 2 | 0.344 | 0.255 | 0.445 | wilson | |
| Risk difference, group 1 minus group 2 | 0.1 | -0.0962 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.778 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 1.53 | 0.638 | 3.64 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Laser Photocoagulation than on Aflibercept 0.4 mg | 9.96 | 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 | Laser Photocoagulation | Participants received laser treatment to each eligible eye at baseline (Day 1), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. If both eyes were eligible, they were assigned to the same treatment group. | 12 | 27 | EG000 |
| Group 2 | Aflibercept 0.4 mg | Participants received one intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (Day 1), 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. If both eyes were eligible, they were assigned to the same treatment group. | 32 | 93 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From signing of informed consent form (ICF) to end of study (week 52 of chronological age visit), an average of 42 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
- NCT number
- NCT04101721
- Phases
- PHASE3
- Conditions
- Retinopathy of Prematurity
- Interventions
- aflibercept, laser photocoagulation
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2023-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04101721?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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