Comparison · NCT00965419-sae
Edivoxetine (Open-Label) vs Edivoxetine (Follow Up): 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. Edivoxetine (Open-Label) vs Edivoxetine (Follow Up): serious adverse events. Trial comparisons, record NCT00965419-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00965419-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 | 0.0265 | 0.0129 | 0.0537 | wilson | |
| Risk in group 2 | 0.0125 | 0.00221 | 0.0675 | wilson | |
| Risk difference, group 1 minus group 2 | 0.014 | -0.0426 | 0.0431 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.12 | 0.265 | 17 | log | |
| Odds ratio, group 1 over group 2 | 2.15 | 0.261 | 17.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Edivoxetine (Open-Label) than on Edivoxetine (Follow Up) | 71.4 | 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 | Edivoxetine (Open-Label) | Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years. | 7 | 264 | EG000 |
| Group 2 | Edivoxetine (Follow Up) | The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days. | 1 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Overall edivoxetine treatment adverse event data were collected for up to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
- NCT number
- NCT00965419
- Phases
- PHASE2, PHASE3
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Edivoxetine
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2018-04-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00965419?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/NCT00965419-sae