Comparison · NCT03650452-sae
TAK-935 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
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ConductScience Library. TAK-935 vs Placebo: serious adverse events. Trial comparisons, record NCT03650452-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03650452-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 | 0.155 | 0.0888 | 0.257 | wilson | |
| Risk in group 2 | 0.186 | 0.112 | 0.292 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0308 | -0.156 | 0.0948 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.834 | 0.401 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 0.804 | 0.333 | 1.94 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TAK-935 than on Placebo | 32.5 | 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 | TAK-935 | TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing \<60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20. | 11 | 71 | EG001 |
| Group 2 | Placebo | TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20. | 13 | 70 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose to 30 days post-last dose of study treatment (Up to 24 weeks)
Source ClinicalTrials.gov
Trial
- Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
- NCT number
- NCT03650452
- Phases
- PHASE2
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Interventions
- TAK-935, Placebo
- Lead sponsor
- Takeda
- Results first posted
- 2021-02-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03650452?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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