Comparison · NCT01052103-sae
LY2140023 + SOC vs Placebo + SOC: 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. LY2140023 + SOC vs Placebo + SOC: serious adverse events. Trial comparisons, record NCT01052103-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01052103-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 | 0.0976 | 0.0503 | 0.181 | wilson | |
| Risk in group 2 | 0.0488 | 0.0191 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0488 | -0.0357 | 0.137 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.627 | 6.38 | log | |
| Odds ratio, group 1 over group 2 | 2.11 | 0.609 | 7.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on LY2140023 + SOC than on Placebo + SOC | 20.5 | 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 | LY2140023 + SOC | 1 week placebo lead-in period followed by 20 milligrams (mg) LY2140023 orally, twice daily for 16 weeks (40 mg/day) treatment period. The dose was allowed to adjust to a minimum of 20 mg/day or a maximum of 80 mg/day plus one of the following Standard of Care (SOC) Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling). | 8 | 82 | EG000 |
| Group 2 | Placebo + SOC | 1 week placebo lead-in period followed by placebo orally, twice daily for 16 weeks (40 mg/day) plus one of the following SOC Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) taken per label (United States labeling) during the treatment period. | 4 | 82 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
- NCT number
- NCT01052103
- Phases
- PHASE2
- Conditions
- Schizophrenia
- Interventions
- LY2140023, Placebo, Standard of Care
- Lead sponsor
- Denovo Biopharma LLC
- Results first posted
- 2021-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01052103?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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