Comparison · NCT04115319-sae
SEP-363856 50 to 100 mg/Day vs Quetiapine XR 400 to 800 mg/Day: 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. SEP-363856 50 to 100 mg/Day vs Quetiapine XR 400 to 800 mg/Day: serious adverse events. Trial comparisons, record NCT04115319-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04115319-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 | 0.0796 | 0.0496 | 0.125 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0363 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0796 | 0.0325 | 0.125 | 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 SEP-363856 50 to 100 mg/Day than on Quetiapine XR 400 to 800 mg/Day | 12.6 | 7.98 | 30.8 | from the risk difference interval |
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 | SEP-363856 50 to 100 mg/Day | Participants received flexible doses of SEP-363856 50 to 100 milligram per day (mg/day), orally, once daily (QD) up to Week 52. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 52. | 16 | 201 | EG000 |
| Group 2 | Quetiapine XR 400 to 800 mg/Day | Participants received flexible doses of quetiapine XR 300 to 800 mg/day, orally, QD up to Week 52. The dose was titrated up from 300 mg/day on Days 1 to 2, followed by 400 mg/day on Days 3 to 4, to 600 mg/day on Days 5 to 7. Beginning Day 8, the dose was adjusted within the range of 400 mg/day to 800 mg/day in 200 mg increments (i.e. 400, 600, or 800 mg/day) up to Week 52. | 0 | 102 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of the study drug up to 7 days after last dose of study drug (Up to 53 weeks)
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
- NCT number
- NCT04115319
- Phases
- PHASE3
- Conditions
- Schizophrenia
- Interventions
- SEP363856, quetiapine XR
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2025-12-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04115319?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/NCT04115319-sae