Comparison · NCT03452943-sae
TEV-50717 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. TEV-50717 vs Placebo: serious adverse events. Trial comparisons, record NCT03452943-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03452943-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 | 0 | 0.0621 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0611 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0611 | 0.0621 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TEV-50717 | Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to \<40 kg was 42 mg/day (21 mg BID), and 20 to \<30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to \<40 kg was 24 mg/day, and 20 to \<30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks. | 0 | 58 | EG000 |
| Group 2 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. | 0 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline (Day 1) to follow-up (Week 14)
Source ClinicalTrials.gov
Trial
- Title
- Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
- NCT number
- NCT03452943
- Phases
- PHASE2, PHASE3
- Conditions
- Tourette Syndrome
- Interventions
- TEV-50717, Placebo
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2020-06-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03452943?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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