Comparison · NCT01986114-sae
SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): 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. SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): serious adverse events. Trial comparisons, record NCT01986114-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01986114-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 | 0.0384 | 0.0247 | 0.0592 | wilson | |
| Risk in group 2 | 0.0603 | 0.0348 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0219 | -0.0662 | 0.011 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.637 | 0.315 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 0.622 | 0.296 | 1.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on SM-13496 20-120mg (Overall, 28 Weeks) than on SM-13496 20-120mg (Japan, 52 Weeks) | 45.6 | 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 | SM-13496 20-120mg (Overall, 28 Weeks) | once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | 19 | 495 | EG000 |
| Group 2 | SM-13496 20-120mg (Japan, 52 Weeks) | once daily orally~SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks | 12 | 199 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
Source ClinicalTrials.gov
Trial
- Title
- A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
- NCT number
- NCT01986114
- Phases
- PHASE3
- Conditions
- Bipolar I Disorder
- Interventions
- SM-13496
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Results first posted
- 2019-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01986114?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/NCT01986114-sae