Comparison · NCT00645099-sae
Paliperidone ER vs Olanzapine: 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. Paliperidone ER vs Olanzapine: serious adverse events. Trial comparisons, record NCT00645099-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00645099-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 | 0.0879 | 0.0582 | 0.131 | wilson | |
| Risk in group 2 | 0.0545 | 0.0315 | 0.0929 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0333 | -0.0152 | 0.0819 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.61 | 0.812 | 3.2 | log | |
| Odds ratio, group 1 over group 2 | 1.67 | 0.801 | 3.48 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Paliperidone ER than on Olanzapine | 30 | 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 | Paliperidone ER | 6-mg or 9-mg tablet once daily flexible dosing for 6 months | 21 | 239 | EG000 |
| Group 2 | Olanzapine | 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months | 12 | 220 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From informed consent up to 6 months (+/- 7 days) of treatment. In case subjects had discontinued before completing treatment, the last data were obtained at the early discontinuation visit.
Source ClinicalTrials.gov
Trial
- Title
- A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
- NCT number
- NCT00645099
- Phases
- PHASE3
- Conditions
- Schizophrenia
- Interventions
- olanzapine, paliperidone ER
- Lead sponsor
- Janssen-Cilag International NV
- Results first posted
- 2010-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00645099?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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