Comparison · NCT01552057-sae
Duloxetine 60 mg vs Placebo: 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. Duloxetine 60 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01552057-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01552057-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 | 0.00515 | 0.000911 | 0.0286 | wilson | |
| Risk in group 2 | 0.0051 | 0.000901 | 0.0283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000526 | -0.0236 | 0.0239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.0636 | 16 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.0627 | 16.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Duloxetine 60 mg than on Placebo | 19,000 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Duloxetine 60 mg | Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily. | 1 | 194 | EG000 |
| Group 2 | Placebo | Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily. | 1 | 196 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline through 1 week post last dose
Source ClinicalTrials.gov
Trial
- Title
- A Study of Duloxetine in Fibromyalgia
- NCT number
- NCT01552057
- Phases
- PHASE3
- Conditions
- Fibromyalgia
- Interventions
- Duloxetine 60 mg, Placebo
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2014-12-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01552057?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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