Comparison · NCT03813238-62369dc4
TEV-50717 vs Placebo: Number of Participants With Adverse Events (AEs)
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. TEV-50717 vs Placebo: Number of Participants With Adverse Events (AEs). Trial comparisons, record NCT03813238-62369dc4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03813238-62369dc4
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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 | 0.875 | 0.739 | 0.945 | wilson | |
| Risk in group 2 | 0.682 | 0.473 | 0.836 | wilson | |
| Risk difference, group 1 minus group 2 | 0.193 | -0.0128 | 0.413 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.943 | 1.75 | log | |
| Odds ratio, group 1 over group 2 | 3.27 | 0.893 | 12 | log | |
| Number needed to treat, for one more participant with the outcome on TEV-50717 than on Placebo | 5.18 | 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 | TEV-50717 | TEV-50717 administered as oral tablets once daily for up to 15 weeks (7 weeks dose titration and 8 weeks maintenance). From Week 1 through Week 7, the dose of TEV-50717 was adjusted according to the titrations scheme (based on body weight and CYP2D6 impairment status at baseline) to identify a dose level that optimally reduced dyskinesia (as determined by the investigator, as indicated by a reduction in the ClinRO of the assessment of the CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 8 weeks. | 35 | 40 | OG001 |
| Group 2 | Placebo | Placebo administered as oral tablets once daily for up to 15 weeks. | 15 | 22 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events (AEs)
- Description
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
- Time frame
- Baseline up to Week 17
- Population
- Safety analysis set included all randomized participants who received at least 1 dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
- NCT number
- NCT03813238
- Phases
- PHASE3
- Conditions
- Cerebral Palsy, Dyskinetic
- Interventions
- TEV-50717, Placebo
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2023-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03813238?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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