Comparison · NCT00412373-sae
Paliperidone Extended-Release (ER) vs Placebo: 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. Paliperidone Extended-Release (ER) vs Placebo: serious adverse events. Trial comparisons, record NCT00412373-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00412373-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 | 0.0514 | 0.0289 | 0.0897 | wilson | |
| Risk in group 2 | 0.0842 | 0.0433 | 0.157 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0328 | -0.109 | 0.0232 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.61 | 0.254 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 0.589 | 0.229 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Paliperidone Extended-Release (ER) than on Placebo | 30.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Paliperidone Extended-Release (ER) | Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine \[5-HT\]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER). | 11 | 214 | EG001 |
| Group 2 | Placebo | A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment. | 8 | 95 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
- NCT number
- NCT00412373
- Phases
- PHASE3
- Conditions
- Schizoaffective Disorder, Psychotic Disorder
- Interventions
- Placebo, Paliperidone ER, Paliperidone ER
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2009-12-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00412373?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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