Comparison · NCT00256997-sae
Risperidone Long-Acting Injection (LAI) vs Oral Atypical Antipsychotic: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Risperidone Long-Acting Injection (LAI) vs Oral Atypical Antipsychotic: serious adverse events. Trial comparisons, record NCT00256997-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00256997-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 | 0.173 | 0.106 | 0.269 | wilson | |
| Risk in group 2 | 0.0698 | 0.0324 | 0.144 | wilson | |
| Risk difference, group 1 minus group 2 | 0.103 | 0.00311 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.48 | 1 | 6.14 | log | |
| Odds ratio, group 1 over group 2 | 2.79 | 1.01 | 7.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Risperidone Long-Acting Injection (LAI) than on Oral Atypical Antipsychotic | 9.7 | 4.84 | 322 | 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 | Risperidone Long-Acting Injection (LAI) | Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | 14 | 81 | EG000 |
| Group 2 | Oral Atypical Antipsychotic | Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. | 6 | 86 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Month 24
Source ClinicalTrials.gov
Trial
- Title
- A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
- NCT number
- NCT00256997
- Phases
- PHASE4
- Conditions
- Schizophrenia
- Interventions
- Risperidone long-acting injection (LAI), Oral atypical Antipsychotic
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Results first posted
- 2013-10-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00256997?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.
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