Comparison · NCT00999609-sae
Intervention vs Control: 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. Intervention vs Control: serious adverse events. Trial comparisons, record NCT00999609-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00999609-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 | 0.1 | 0.0279 | 0.301 | wilson | |
| Risk in group 2 | 0 | 0 | 0.299 | wilson | |
| Risk difference, group 1 minus group 2 | 0.1 | -0.208 | 0.301 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Intervention than on Control | 10 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention | Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart | 2 | 20 | EG000 |
| Group 2 | Control | No intervention, no sham; uninjected control group | 0 | 9 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year post administration (Intervention group), 1 year post baseline (Control group)
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study in Subjects With Leber Congenital Amaurosis
- NCT number
- NCT00999609
- Phases
- PHASE3
- Conditions
- Inherited Retinal Dystrophy Due to RPE65 Mutations, Leber Congenital Amaurosis
- Interventions
- AAV2-hRPE65v2,voretigene neparvovec-rzyl
- Lead sponsor
- Spark Therapeutics, Inc.
- Results first posted
- 2018-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00999609?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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