Comparison · NCT01687478-sae
Olanzapine + Fluoxetine vs Placebo + Fluoxetine: 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. Olanzapine + Fluoxetine vs Placebo + Fluoxetine: serious adverse events. Trial comparisons, record NCT01687478-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01687478-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 | 0.0114 | 0.00201 | 0.0616 | wilson | |
| Risk in group 2 | 0.0115 | 0.00203 | 0.0623 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000131 | -0.0518 | 0.051 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.989 | 0.0628 | 15.6 | log | |
| Odds ratio, group 1 over group 2 | 0.989 | 0.0608 | 16.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Olanzapine + Fluoxetine than on Placebo + Fluoxetine | 7,660 | 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 | Olanzapine + Fluoxetine | Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.~Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks. | 1 | 88 | EG000 |
| Group 2 | Placebo + Fluoxetine | Placebo matches the Olanzapine tablet for blinding.~Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks. | 1 | 87 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression
- NCT number
- NCT01687478
- Phases
- PHASE3
- Conditions
- Treatment Resistant Depression
- Interventions
- Olanzapine, Fluoxetine, Placebo
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2017-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01687478?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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