Comparison · NCT01157351-sae
Paliperidone Palmitate vs Oral Antipsychotics: 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 Palmitate vs Oral Antipsychotics: serious adverse events. Trial comparisons, record NCT01157351-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01157351-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 | 0.186 | 0.141 | 0.242 | wilson | |
| Risk in group 2 | 0.243 | 0.191 | 0.304 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0573 | -0.133 | 0.0191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.764 | 0.534 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.711 | 0.45 | 1.12 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Paliperidone Palmitate than on Oral Antipsychotics | 17.5 | 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 Palmitate | Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months. | 42 | 226 | EG000 |
| Group 2 | Oral Antipsychotics | One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months. | 53 | 218 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
- NCT number
- NCT01157351
- Phases
- PHASE4
- Conditions
- Schizophrenia
- Interventions
- paliperidone, risperidone, haloperidole, perphenazine, aripiprazole, quetiapine, paliperidone palmitate, olanzapine
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Results first posted
- 2014-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01157351?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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