Comparison · NCT01052103-e8568866
LY2140023 + SOC vs Placebo + SOC: Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)
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. LY2140023 + SOC vs Placebo + SOC: Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs). Trial comparisons, record NCT01052103-e8568866. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01052103-e8568866
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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 | 0.037 | 0.0127 | 0.103 | wilson | |
| Risk in group 2 | 0.0122 | 0.00216 | 0.0659 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0248 | -0.0341 | 0.0919 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.04 | 0.323 | 28.6 | log | |
| Odds ratio, group 1 over group 2 | 3.12 | 0.317 | 30.6 | log | |
| Number needed to treat, for one more participant with the outcome on LY2140023 + SOC than on Placebo + SOC | 40.3 | 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). | 3 | 81 | OG000 |
| 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. | 1 | 82 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)
- Description
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using the Fridericia formula. A potentially clinically significant change in QTcF is defined as \>450 milliseconds (ms) for male and \>470 ms for female.
- Time frame
- Baseline to randomization treatment Week 16
- Population
- All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline ECG QTcF measurement.
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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