Comparison · NCT02234583-sae
DS-5565 15 mg QD Modal vs DS-5565 15 mg BID Modal: 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. DS-5565 15 mg QD Modal vs DS-5565 15 mg BID Modal: serious adverse events. Trial comparisons, record NCT02234583-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02234583-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 | 0.0484 | 0.0359 | 0.065 | wilson | |
| Risk in group 2 | 0.0757 | 0.0623 | 0.0918 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0273 | -0.0477 | -0.00597 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.639 | 0.448 | 0.913 | log | |
| Odds ratio, group 1 over group 2 | 0.621 | 0.425 | 0.906 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on DS-5565 15 mg QD Modal than on DS-5565 15 mg BID Modal | 36.6 | 21 | 167 | from the risk difference interval |
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 | DS-5565 15 mg QD Modal | Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal. | 41 | 847 | EG000 |
| Group 2 | DS-5565 15 mg BID Modal | Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo twice daily (BID) modal. | 94 | 1,241 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after last dose, up to 2 years 3 months.
Source ClinicalTrials.gov
Trial
- Title
- An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
- NCT number
- NCT02234583
- Phases
- PHASE3
- Conditions
- Pain Associated With Fibromyalgia
- Interventions
- DS-5565
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2020-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02234583?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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