Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00632 | 0.00446 | 0.00896 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00245 | 0.0014 | 0.00427 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00387 | 0.00126 | 0.00671 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 2.58 | 1.33 | 5.02 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.59 | 1.33 | 5.05 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Sertindole than on Risperidone | 258 | 149 | 791 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Sertindole | Normally in the range of 4 to 20 mg/day | 31 | 4,905 | OG000 | ClinicalTrials.gov |
| Group 2 | Risperidone | Normally in the range of 2 to 8 mg/day | 12 | 4,904 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | ClinicalTrials.gov |
| Description | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | ClinicalTrials.gov |
| Time frame | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | ClinicalTrials.gov |
| Population | The analysis population included all patients who took at least one dose of study drug. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use | ClinicalTrials.gov |
| NCT number | NCT00856583 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Schizophrenia | ClinicalTrials.gov |
| Interventions | Sertindole, Risperidone | ClinicalTrials.gov |
| Lead sponsor | H. Lundbeck A/S | ClinicalTrials.gov |
| Results first posted | 2011-08-01 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00856583?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.