Comparison · NCT02091375-sae
GWP42003-P 20 mg/kg/Day Dose 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. GWP42003-P 20 mg/kg/Day Dose vs Placebo: serious adverse events. Trial comparisons, record NCT02091375-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02091375-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 | 0.164 | 0.0916 | 0.276 | wilson | |
| Risk in group 2 | 0.0508 | 0.0174 | 0.139 | wilson | |
| Risk difference, group 1 minus group 2 | 0.113 | -0.0011 | 0.23 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.22 | 0.933 | 11.1 | log | |
| Odds ratio, group 1 over group 2 | 3.66 | 0.954 | 14 | log | |
| Number needed to harm, for one more participant with a serious adverse event on GWP42003-P 20 mg/kg/Day Dose than on Placebo | 8.84 | 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 | GWP42003-P 20 mg/kg/Day Dose | Participants received 20 mg/kg/day of GWP42003-P administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period. | 10 | 61 | EG000 |
| Group 2 | Placebo | Participants received placebo (0 mg/mL CBD), volume-matched to the 20 mg/kg/day dose level, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period. | 3 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 (after dosing) to Day 137
Source ClinicalTrials.gov
Trial
- Title
- Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
- NCT number
- NCT02091375
- Phases
- PHASE3
- Conditions
- Epilepsy, Dravet Syndrome
- Interventions
- GWP42003-P 20 mg/kg/day Dose, Placebo control
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2018-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02091375?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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