Comparison · NCT06107803-sae
Treatment Phase 1 vs Treatment Phase 2: 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. Treatment Phase 1 vs Treatment Phase 2: serious adverse events. Trial comparisons, record NCT06107803-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06107803-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 | 0.0588 | 0.0105 | 0.27 | wilson | |
| Risk in group 2 | 0 | 0 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0588 | -0.151 | 0.27 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Treatment Phase 1 than on Treatment Phase 2 | 17 | 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 | Treatment Phase 1 | Roluperidone 64 mg monotherapy administered as an oral dose daily for 7 days on Days 1-7.~Roluperidone 64 mg: 64 mg/day oral | 1 | 17 | EG000 |
| Group 2 | Treatment Phase 2 | Roluperidone 64 mg oral and olanzapine 10 mg oral administered at the same time daily for 10 days on Days 8-17.~Roluperidone 64 mg: 64 mg/day oral~Olanzapine 10 MG: 10 mg/day oral | 0 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment through end of study (Day 17).
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
- NCT number
- NCT06107803
- Phases
- PHASE1
- Conditions
- Negative Symptoms in Schizophrenia
- Interventions
- Roluperidone 64 mg, Olanzapine 10 MG
- Lead sponsor
- Minerva Neurosciences
- Results first posted
- 2025-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06107803?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.govNone 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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