Comparison · NCT01662648-sae
Paliperidone ER: Lack of Efficacy vs Paliperidone ER: Lack of Tolerability, Compliance or Other: 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: Lack of Efficacy vs Paliperidone ER: Lack of Tolerability, Compliance or Other: serious adverse events. Trial comparisons, record NCT01662648-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01662648-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 | 0.0684 | 0.0496 | 0.0936 | wilson | |
| Risk in group 2 | 0.0494 | 0.0346 | 0.0701 | wilson | |
| Risk difference, group 1 minus group 2 | 0.019 | -0.00897 | 0.0482 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 0.858 | 2.23 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 0.85 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Paliperidone ER: Lack of Efficacy than on Paliperidone ER: Lack of Tolerability, Compliance or Other | 52.8 | 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: Lack of Efficacy | Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. | 35 | 512 | EG000 |
| Group 2 | Paliperidone ER: Lack of Tolerability, Compliance or Other | Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons. | 29 | 587 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 26 weeks
Source ClinicalTrials.gov
Trial
- Title
- Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
- NCT number
- NCT01662648
- Phases
- PHASE3
- Conditions
- Schizophrenia
- Interventions
- Paliperidone ER
- Lead sponsor
- Janssen Pharmaceutica
- Results first posted
- 2014-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01662648?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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