Comparison · NCT04572243-5960d347
Core Study: Lorcaserin vs Core Study: Placebo: Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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. Core Study: Lorcaserin vs Core Study: Placebo: Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT04572243-5960d347. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04572243-5960d347
On this page
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 | 0.818 | 0.523 | 0.949 | wilson | |
| Risk in group 2 | 0.7 | 0.397 | 0.892 | wilson | |
| Risk difference, group 1 minus group 2 | 0.118 | -0.234 | 0.448 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.714 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 1.93 | 0.25 | 14.9 | log | |
| Number needed to treat, for one more participant with the outcome on Core Study: Lorcaserin than on Core Study: Placebo | 8.46 | 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 | Core Study: Lorcaserin | Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks. | 9 | 11 | OG001 |
| Group 2 | Core Study: Placebo | Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks. | 7 | 10 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product.
- Time frame
- From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)
- Population
- The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
- NCT number
- NCT04572243
- Phases
- PHASE3
- Conditions
- Epilepsies, Myoclonic
- Interventions
- Placebo, Lorcaserin
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2025-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04572243?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04572243-5960d347