Comparison · NCT02926898-sae
Cohort 2: ZX008 0.5 mg/kg/Day vs Cohort 2: Matching 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. Cohort 2: ZX008 0.5 mg/kg/Day vs Cohort 2: Matching Placebo: serious adverse events. Trial comparisons, record NCT02926898-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02926898-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 | 0.14 | 0.0656 | 0.273 | wilson | |
| Risk in group 2 | 0.159 | 0.0793 | 0.294 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0196 | -0.173 | 0.136 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.877 | 0.321 | 2.4 | log | |
| Odds ratio, group 1 over group 2 | 0.857 | 0.263 | 2.79 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort 2: ZX008 0.5 mg/kg/Day than on Cohort 2: Matching Placebo | 51.1 | 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 | Cohort 2: ZX008 0.5 mg/kg/Day | ZX008 0.5 mg/kg/day (maximum 20 mg/day) dose administered twice a day (BID) in equally divided doses. | 6 | 43 | EG000 |
| Group 2 | Cohort 2: Matching Placebo | Matching placebo administered twice a day (BID) in equally divided doses. | 7 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The period of observation for Adverse Events extended from the time the subject gave informed consent until the end of the Follow-up Visit (up to Day 120 [Visit 13]).
Source ClinicalTrials.gov
Trial
- Title
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
- NCT number
- NCT02926898
- Phases
- PHASE3
- Conditions
- Dravet Syndrome
- Interventions
- ZX008 (Fenfluramine Hydrochloride), Matching Placebo
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Results first posted
- 2022-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02926898?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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