Rollover Cohort: SD-809 ER vs Switch Cohort: SD-809 ER: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.256 | 0.174 | 0.36 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.297 | 0.175 | 0.458 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0412 | -0.221 | 0.119 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.861 | 0.464 | 1.6 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.814 | 0.344 | 1.93 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rollover Cohort: SD-809 ER than on Switch Cohort: SD-809 ER | 24.3 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Rollover Cohort: SD-809 ER | Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. | 21 | 82 | EG000 | ClinicalTrials.gov |
| Group 2 | Switch Cohort: SD-809 ER | Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant's prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. | 11 | 37 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Baseline to follow-up visit (up to approximately 3 years 9 months) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Alternatives for Reducing Chorea in Huntington Disease | ClinicalTrials.gov |
| NCT number | NCT01897896 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Chorea Associated With Huntington Disease | ClinicalTrials.gov |
| Interventions | SD-809 | ClinicalTrials.gov |
| Lead sponsor | Auspex Pharmaceuticals, Inc. | ClinicalTrials.gov |
| Results first posted | 2019-04-16 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01897896?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.