Comparison · NCT02198794-sae
Part A and Part B Participants vs Part C: SD-809: 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. Part A and Part B Participants vs Part C: SD-809: serious adverse events. Trial comparisons, record NCT02198794-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02198794-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 | 0.202 | 0.162 | 0.248 | wilson | |
| Risk in group 2 | 0.0625 | 0.027 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.139 | 0.054 | 0.197 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.23 | 1.35 | 7.74 | log | |
| Odds ratio, group 1 over group 2 | 3.79 | 1.48 | 9.74 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Part A and Part B Participants than on Part C: SD-809 | 7.18 | 5.06 | 18.5 | 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 | Part A and Part B Participants | Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. Participants who agreed to participate in Part B, received SD-809 or placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks. | 68 | 337 | EG000 |
| Group 2 | Part C: SD-809 | EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B. | 5 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)
Source ClinicalTrials.gov
Trial
- Title
- Reducing Involuntary Movements in Participants With Tardive Dyskinesia
- NCT number
- NCT02198794
- Phases
- PHASE3
- Conditions
- Tardive Dyskinesia
- Interventions
- SD-809, Placebo
- Lead sponsor
- Auspex Pharmaceuticals, Inc.
- Results first posted
- 2021-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02198794?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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